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  • HP:0001909: Leukemia
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    HP:0001909: Leukemia

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (22)


    Name (Synonyms) Correlation
    drug484 BMS-986253 Wiki 0.27
    drug3202 Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Wiki 0.27
    drug2819 Part 2 - TL-895 Wiki 0.27
    Name (Synonyms) Correlation
    drug3179 Quality of life assessment Wiki 0.27
    drug1866 IO-202 Dose Expansion Wiki 0.27
    drug424 Azithromycin 250 MG Oral Capsule Wiki 0.27
    drug2817 Part 1 - TL-895 Wiki 0.27
    drug2818 Part 2 - Placebo Wiki 0.27
    drug3866 TAK-981 Wiki 0.27
    drug1169 Data registry Wiki 0.27
    drug3199 Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index Wiki 0.27
    drug3685 Spectrila® Wiki 0.27
    drug1865 IO-202 Dose Escalation Wiki 0.27
    drug2833 Patient Status Engine Wiki 0.27
    drug1935 Informed consent Wiki 0.27
    drug1800 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.19
    drug4238 Virtual Reality Wiki 0.19
    drug2049 Ixazomib Wiki 0.19
    drug3135 Psychoeducation Wiki 0.19
    drug2979 Placebo oral capsule Wiki 0.15
    drug3738 Standard of care Wiki 0.05
    drug2981 Placebo oral tablet Wiki 0.05

    Correlated MeSH Terms (14)


    Name (Synonyms) Correlation
    D019337 Hematologic Neoplasms NIH 0.76
    D007938 Leukemia, NIH 0.65
    D007945 Leukemia, Lymphoid NIH 0.46
    Name (Synonyms) Correlation
    D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.46
    D015470 Leukemia, Myeloid, Acute NIH 0.38
    D007951 Leukemia, Myeloid, NIH 0.27
    D010007 Osteochondritis NIH 0.27
    D015479 Leukemia, Myelomonocytic, Acute NIH 0.27
    D015477 Leukemia, Myelomonocytic, Chronic NIH 0.27
    D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.27
    D008223 Lymphoma, NIH 0.22
    D009369 Neoplasms, NIH 0.18
    D007239 Infection NIH 0.01
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (8)


    Name (Synonyms) Correlation
    HP:0005526 Lymphoid leukemia HPO 0.46
    HP:0004808 Acute myeloid leukemia HPO 0.38
    HP:0012324 Myeloid leukemia HPO 0.27
    Name (Synonyms) Correlation
    HP:0012325 Chronic myelomonocytic leukemia HPO 0.27
    HP:0004820 Acute myelomonocytic leukemia HPO 0.27
    HP:0005550 Chronic lymphatic leukemia HPO 0.27
    HP:0002665 Lymphoma HPO 0.22
    HP:0002664 Neoplasm HPO 0.18

    Clinical Trials

    Navigate: Correlations   HPO

    There are 14 clinical trials


    1 A Clinical Phase II Trial to Describe Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Spectrila® With the Pharmaceutical Active Ingredient Recombinant L Asparaginase in Adult Subjects With Newly Diagnosed Acute B-Cell Lymphoblastic Leukaemia

    This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for first-line treatment of ALL patients of all age groups and showed similar efficacy and safety in comparison to Asparaginase medac no blinding or control groups are necessary. As underlying treatment protocol the BRALL 2014 treatment protocol will be used.

    NCT03156790
    Conditions
    1. Acute B-Cell Lymphoblastic Leukaemia
    Interventions
    1. Drug: Spectrila®
    MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
    HPO:Leukemia Lymphoid leukemia

    Primary Outcomes

    Description: Assessment of induction phase response, defined as subjects with asparaginase (ASNase) activity trough levels in serum ≥ 100 U/L in induction phase

    Measure: Asparaginase (ASNase) activity trough levels

    Time: Day 21 until Day 31
    2 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019

    The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in dose escalation and cancer treatment expansions, and to assess change in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID expansion.

    NCT03648372
    Conditions
    1. Neoplasms
    2. Lymphoma
    3. Hematologic Neoplasms
    4. Coronavirus Disease
    Interventions
    1. Drug: TAK-981
    2. Drug: Standard of care
    MeSH:Coronavirus Infections Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Dose Limiting Toxicities (DLTs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More Serious Adverse Events (SAEs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Laboratory Values

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Vital Sign Measurements

    Time: Up to 36 months

    Description: CRS will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants who Experience Cytokine Release Syndrome CRS)

    Time: Up to 36 months

    Measure: COVID-19 Expansion: Number of Participants With >=2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Secondary Outcomes

    Measure: Dose Escalation and Cancer Treatment Expansions, Cmax: Maximum Observed Plasma Concentration for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Terminal Disposition Phase Half-life (t1/2z) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Total Clearance After Intravenous Administration (CL) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Description: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR) through the study (approximately 3 years), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors and Response Evaluation Criteria in Lymphoma (RECIL) for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Overall Response Rate (ORR)

    Time: From the first dose until best response is achieved (up to approximately 3 years)

    Description: DOR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Duration of Response (DOR)

    Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to approximately 3 years)

    Description: DCR is defined as percentage of participants who achieve stable disease (SD) or better greater than (>) 6 weeks during the study in response-evaluable population, as determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Disease Control Rate (DCR)

    Time: From the first dose until best response is achieved (up to approximately 3 years)

    Description: PFS will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Progression-free Survival (PFS)

    Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to approximately 3 years)

    Description: TTR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Time to Response (TTR)

    Time: From the date of first study drug administration to the date of first documented PR or better (up to approximately 3 years)

    Measure: Dose Escalation and Cancer Treatment Expansions: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Post-dose Skin or Tumor Biopsies

    Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose Skin or Tumor Biopsies at Each Dose Level

    Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

    Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs

    Time: Up to 9 months

    Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.

    Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Number of Participants Based on Duration of TEAEs

    Time: Up to 9 months

    Description: CRS will be graded as per ASTCT Consensus Grading for CRS.

    Measure: COVID-19 Expansion: Number of Participants who Experience CRS

    Time: Up to 9 months

    Description: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

    Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS)

    Time: Up to 9 months

    Description: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).

    Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating

    Time: Up to 9 months

    Description: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.

    Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30

    Time: Days 3, 5, 8, 11, 15, and 30

    Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Duration of Hospitalization

    Time: Up to 9 months

    Description: Time from the first dose of TAK-981 to viral load negativity (below level of detection).

    Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Description: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

    Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days

    Time: Days 30 and 90
    3 Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma

    The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.

    NCT03888534
    Conditions
    1. Precursor Cell Lymphoblastic Leukemia-lymphoma
    Interventions
    1. Drug: Ixazomib
    MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
    HPO:Leukemia Lymphoid leukemia Lymphoma

    Primary Outcomes

    Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.

    Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy

    Time: Up to Day 29

    Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Time: Up to 30 months

    Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters

    Time: Up to 30 months

    Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib

    Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

    Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib

    Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

    Secondary Outcomes

    Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).

    Measure: Overall Response Rate (ORR)

    Time: Up to 30 months
    4 Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adults With Leukemia: a Feasibility Study

    The goal of this feasibility study is to determine if Virtual Reality (VR) can be adequately used as an alternative to General Anesthesia (GA) for Lumbar Punctures (LP).

    NCT04092803
    Conditions
    1. Leukemia
    Interventions
    1. Other: Virtual Reality
    MeSH:Leukemia
    HPO:Leukemia

    Primary Outcomes

    Description: This is a feasibility study with the primary outcome defined as success of completion of the Lumbar Puncture with Virtual Reality.

    Measure: Success of completion of the LP with VR

    Time: 4 months

    Secondary Outcomes

    Description: This is a numerical scale from 0 to 10, 0 being no pain, 10 being the worst possible pain.

    Measure: Pain Visual Analogue Scale (Pain VAS)

    Time: 4 months

    Description: The CAM-S is a vertical analog scale for child self-report of state anxiety. Children are asked to rate how nervous or worried they feel "right now" by marking a line on a visual depiction of a thermometer. Lines closet to the bottom of the thermometer indicate less worry, while lines towards the top of the thermometer indicate more worry. The scale ranges from Calm (score of 0) to very very nervous (score of 100)

    Measure: Child Anxiety Meter-State (CAM-S)

    Time: 4 months

    Description: The Children's fear Scale is a one-item scale that consists of a row of faces with expressions ranging from no fear (score of 0) to extreme fear (score of 4). Children are asked to choose the face that most closely reflects how anxious or fearful they are feeling.

    Measure: Children's Fear Scale (CFS)

    Time: 4 months
    5 A Randomized Phase 2 Study of Anti-IL-8 Therapy Versus Standard of Care in the Treatment of Hospitalized Patients With Severe COVID-19

    This study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of participants infected with COVID-19. This is the first in-human study of this investigational product specifically in patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.

    NCT04347226
    Conditions
    1. Solid Tumor
    2. Sars-CoV2
    3. Hematological Malignancy
    Interventions
    1. Drug: BMS-986253
    MeSH:Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia

    Primary Outcomes

    Description: The time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.

    Measure: Time to Improvement in the 7-point ordinal scale

    Time: 1 year

    Secondary Outcomes

    Description: The time to death will be defined as the time from onset from symptoms until death from any cause. Patients who are alive or lost to follow-up at the cut-off date will be censored from this analysis.

    Measure: Time to Death

    Time: 1 year

    Description: The time to intubation will be defined as the time from symptom onset until time of intubation. Any patients already intubated at enrollment will be censored from this analysis.

    Measure: Time to Intubation

    Time: 1 year

    Description: The proportion of patients requiring intensive care unit (ICU) admission will be calculated as the number of patients requiring ICU admission over the course of their hospitalization over the number of evaluable patients.

    Measure: Proportion of patients requiring ICU admission

    Time: 1 year

    Description: Percentage of participants who have died 1 month from the time of start of treatment

    Measure: Percentage Rate of Mortality at 1 month

    Time: 1 month
    6 SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance

    This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.

    NCT04352556
    Conditions
    1. SARS-CoV-2 Infection
    2. Hematological Malignancies
    MeSH:Infection Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: The percentage of HM patients with COVID-19 who died.

    Measure: To evaluate mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.

    Measure: To evaluate potential predictive biochemical parameters of mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.

    Measure: To evaluate potential predictive HM-related parameters of mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality

    Measure: To evaluate COVID severity as predictive parameter of mortality.

    Time: At 2 months from study initiation

    Secondary Outcomes

    Description: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)

    Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity

    Time: At 6 months from study initiation

    Description: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.

    Measure: Definition of complete clinical picture of COVID-19 in HM

    Time: At 2 months from study initiation

    Description: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.

    Measure: Evolution of HM

    Time: At 2 months from study initiation

    Description: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).

    Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics

    Time: At 2 months from study initiation

    Measure: Viral dynamics in infected HM patients

    Time: At 12 months from study initiation
    7 A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered IO-202 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)

    To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D) and dose schedule as monotherapy.

    NCT04372433
    Conditions
    1. AML M5
    2. AML M4
    3. AML, Nos
    4. Acute Myelogenous Leukemia in Relapse
    5. Myelomonocytic Leukemia, Chronic
    Interventions
    1. Drug: IO-202 Dose Escalation
    2. Drug: IO-202 Dose Expansion
    MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute
    HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Acute myelomonocytic leukemia Chronic myelomonocytic leukemia Leukemia Myeloid leukemia

    Primary Outcomes

    Description: Incidence of adverse events

    Measure: Safety of IO-202 as measured by incidence of adverse events.

    Time: From first dose of IO-202 to 30 days following last study treatment

    Description: Severity of adverse events

    Measure: Safety of IO-202 as measured by severity of adverse events.

    Time: From first dose of IO-202 to 30 days following last study treatment

    Description: Incidence dose interruptions and dose reductions

    Measure: Tolerability of IO-202 as measured by incidence and duration of dose interruptions and dose reductions of study treatment

    Time: From first dose of IO-202 to 30 days following last study treatment

    Secondary Outcomes

    Description: Maximum concentration (Cmax) of IO-202

    Measure: To characterize the pharmacokinetics (PK) of IO-202 as defined by maximum plasma concentration (Cmax)

    Time: Through study completion, an average of 1 year

    Description: measure area under the curve (AUC) of IO-202

    Measure: To characterize the PK of IO-202 as defined by area under the curve (AUC)

    Time: Through study completion, an average of 1 year

    Description: Measure anti-drug antibodies in plasma.

    Measure: To evaluate the incidence of anti-drug antibodies against IO-202

    Time: Through study completion, an average of 1 year

    Description: Measure response rates in patients with anti-drug antibodies.

    Measure: To measure rates of response to IO-202 in patients with anti-drug antibodies

    Time: Through study completion, an average of 1 year

    Other Outcomes

    Description: Statistical correlation levels of target expression on leukemic blasts with response rate

    Measure: To correlate target expression with response rates

    Time: Through study completion, a average of 1 year

    Description: Statistical correlation of target expression on leukemic blasts with adverse event rates

    Measure: To correlate target expression with rates of adverse events

    Time: Through study completion, a average of 1 year

    Description: Measure immunophenotype of leukemic blasts from bone marrow aspirates after study treatment

    Measure: To evaluate immunophenotype of leukemic blasts after study treatment.

    Time: Through study completion, a average of 1 year
    8 A Pilot Study Evaluating Feasibility, Acceptability, Usability, Satisfaction and Preliminary Efficacy of an Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy

    The purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.

    NCT04390542
    Conditions
    1. Blood Cancer
    Interventions
    1. Behavioral: Psychoeducation
    MeSH:Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia

    Primary Outcomes

    Description: Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)

    Measure: Time to identify and recruit dyads in months

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Feasibility, as measured by accrual rates of eligible participants

    Measure: Accrual rates

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Feasibility, as measured by retention rate

    Measure: Retention rate

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Feasibility as measured by completion of data collection across study timepoints

    Measure: Data collection completion rate

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Acceptability, as measured by average acceptability scale scores, with overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.

    Measure: Average acceptability scale scores

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Usability, as measured by average System Usability Scale scores. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores > 68 considered to be above average usability.

    Measure: Average System Usability Scale scores

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores >7 will be considered acceptable. Mean and standard deviation to describe subjects' overall satisfaction with the intervention reported.

    Measure: Mean caregiver satisfaction

    Time: 2 months post-hospital discharge, an average of 2 months

    Description: End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction.

    Measure: End-of-study caregiver satisfaction scores

    Time: 2 months post-hospital discharge, an average of 2 months

    Secondary Outcomes

    Description: Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender

    Measure: Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores

    Time: Baseline, hospital discharge, 2 months post hospital discharge

    Description: Caregiver HRQOL, evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes.

    Measure: Caregiver Healthcare Related Quality Of Life (HRQOL)

    Time: Baseline, hospital discharge, 2 months post hospital discharge

    Description: Distress as measured by the NCCN distress thermometer. Thermometer scores range from 0 to 10, with higher scores indicating worse distress. Prior to administration of the distress thermometer measure, each caregiver will be asked if they are experiencing distress related to Covid-19 (yes/no). The distress thermometer asking them to rate their distress in the past week including today. The Covid-19 variable will be included as a covariate in the analyses. Evaluated for changes over 3 time points using repeated measures analysis of variance (RMANOVA)-between and within model- controlling for caregiver age, race, and gender

    Measure: Distress as measured by the the NCCN distress thermometer

    Time: Baseline, hospital discharge, 2 months post hospital discharge
    9 National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

    The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012. Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.

    NCT04391946
    Conditions
    1. Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
    Interventions
    1. Behavioral: Data registry
    MeSH:Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Osteochondritis
    HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma

    Primary Outcomes

    Description: Hematological pathology Description

    Measure: Prognostic factors for healing of COVID-19 infection

    Time: Day 0

    Secondary Outcomes

    Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.

    Measure: Medical care of Coronavirus infection

    Time: within 12 months after diagnosis

    Description: Allow national epidemiological monitoring and regularly inform the hematology community.

    Measure: national epidemiological monitoring

    Time: through study completion, an average of 2 years
    10 Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies

    The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

    NCT04392128
    Conditions
    1. COVID19
    2. Hematologic Malignancy
    Interventions
    1. Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
    2. Drug: Azithromycin 250 MG Oral Capsule
    3. Drug: Placebo oral tablet
    4. Drug: Placebo oral capsule
    MeSH:Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.

    Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.

    Time: 5 days of treatment

    Secondary Outcomes

    Description: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)

    Measure: Clinical evolution

    Time: up to 3 months

    Description: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock

    Measure: Proportion of patients progressing to a severe form

    Time: up to 3 months

    Description: Date and cause of death

    Measure: Mortality

    Time: up to 1 and 3 months

    Description: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples

    Measure: Evaluation of viral load drop

    Time: at day 10

    Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)

    Measure: Tolerance of study treatment

    Time: up to 3 months

    Description: Collection of serum to realize serological tests

    Measure: Evaluation of the seroconversion

    Time: at inclusion, day 10, day 30 and day 90 after treatment

    Description: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.

    Measure: NK immunological study

    Time: at day 10 and day 30 after treatment

    Description: Duration of hospitalisation (conventional, intensive care, reanimation)

    Measure: Hospitalisation duration

    Time: up to 3 months

    Description: Patient follow-up during 3 months : hematological status and associated therapy

    Measure: Impact of the study treatment on the treatment of the hematological disease

    Time: up to 3 months

    Description: ECG (using connected machine to allow monitoring at home)

    Measure: Monitoring of the QT space

    Time: at inclusion, day 2, day 5, day 10

    Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.

    Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine.

    Time: at day 5 and day 10

    Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.

    Measure: T immunological study

    Time: at day 10 and day 30 after treatment
    11 Remote Monitoring of Cancer Patients Presenting With Symptoms Suggestive of Covid-19 - Pilot Phase.

    Since emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to cause a wide range of clinical syndromes, from fever, dyspnoea and cough to respiratory failure and cardiac injury necessitating critical care support. A number of patients have a more indolent clinical course and can be safely managed in the community. Characterising the clinical course of Covid-19 infection in the oncology population and distinguishing this from other acute oncology presentations which can mimic Covid-19 is a key unmet research need. Current standard of care for monitoring patients at high risk of chemotherapy associated neutropenic sepsis involves asking them to contact their cancer centre when they feel unwell or develop a fever. No standard of care for monitoring ambulatory Covid-19 patients has yet been established. We hypothesise that using wearable biosensors to detect patients who exhibit 'red flags' for sepsis or deterioration due to Covid-19 may allow earlier assessment and intervention. There is no current evidence for wearable biosensors in ambulatory patients receiving chemotherapy, and there is no existing research into this proposed use of biosensors in patients with suspected or confirmed Covid-19 infection. In order to justify performing a randomised controlled study comparing standard of care with biosensor driven monitoring it is important to establish the tolerability and validity of these devices. We aim to collect patient reported outcome measures (PROMs) on tolerability and assess the reliability of data transmission to a central data collection server. We will also perform an initial analysis of physiological data and correlation with clinical events

    NCT04397705
    Conditions
    1. COVID
    2. Oncology
    3. Haematological Malignancy
    Interventions
    1. Device: Patient Status Engine
    MeSH:Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia

    Primary Outcomes

    Description: Percentage of patients who choose to stop wearing the devices before they have completed the study

    Measure: Device Tolerability (Attrition)

    Time: Three weeks

    Description: Correlation of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature.

    Measure: Correlation of physiological data with clinical events

    Time: Over three weeks of patients wearing devices

    Secondary Outcomes

    Description: Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again for the next three weeks'. This statement is included in the questionnaires completed after three weeks of wearing the device.

    Measure: Device Tolerability (Questionnaire)

    Time: Questionnaire at three weeks

    Description: Device tolerability as assessed by semi-structured interviews.

    Measure: Device Tolerability (Semi-structured interviews)

    Time: One to four weeks after completion of wearing the device

    Description: Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.

    Measure: Reliability of data transmission

    Time: Over three weeks of patients wearing devices
    12 A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer

    This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.

    NCT04419623
    Conditions
    1. COVID-19
    2. Sars-CoV2
    3. Cancer
    4. Solid Tumor
    5. Carcinoma
    6. Blood Cancer
    Interventions
    1. Drug: Part 1 - TL-895
    2. Drug: Part 2 - TL-895
    3. Drug: Part 2 - Placebo
    MeSH:Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia

    Primary Outcomes

    Description: To determine the recommended dose of TL-895 to be used in Part 2 based on the observed dose limiting toxicity per dose level

    Measure: Part 1 - Recommended dose of TL-895

    Time: After the day 14 of the 6th subject per dose level

    Description: The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death

    Measure: Part 2 - Change in the need for artificial ventilation or death

    Time: Day 29

    Secondary Outcomes

    Description: The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death

    Measure: Part 2 - Change in respiratory failure events that require invasive ventilation or death

    Time: 4 months
    13 National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

    The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.

    NCT04452604
    Conditions
    1. Acute Myeloblastic Leukemia
    2. Acute Lymphoblastic Leukemia
    3. SARS-CoV-2
    MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute
    HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia

    Primary Outcomes

    Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)

    Measure: Clinical prognostic factors for infection with COVID-19

    Time: Day 0

    Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection

    Measure: Biological prognostic factors for infection with COVID-19

    Time: Day 0

    Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death

    Measure: Medical care of Coronavirus infection

    Time: within 12 months after diagnosis
    14 An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs

    This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.

    NCT04581187
    Conditions
    1. Hematologic Malignancies
    Interventions
    1. Other: Quality of life assessment
    MeSH:Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: HRQOL in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Description: To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: Symptoms in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Description: To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: Adherence to therapy in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Secondary Outcomes

    Description: To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)

    Measure: Prevalence of clinically relevant functional limitations and symptoms

    Time: After 2 years from date of registration

    Description: To investigate factors associated with physical and mental health concerns

    Measure: Factors associated with physical and mental health concerns

    Time: After 2 years from date of registration

    Description: To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes

    Measure: Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes

    Time: After 2 years from date of registration

    Description: To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes

    Measure: Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes

    Time: After 2 years from date of registration

    Description: To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios

    Measure: Clinical strategies adopted by physicians

    Time: After 2 years from date of registration

    HPO Nodes


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    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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