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D019337: Hematologic Neoplasms

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 (13)


Name (Synonyms) Correlation
drug2426 Part 1 - TL-895 Wiki 0.38
drug2428 Part 2 - TL-895 Wiki 0.38
drug1652 Individualised Ayurveda Wiki 0.38
Name (Synonyms) Correlation
drug367 Azithromycin 250 MG Oral Capsule Wiki 0.38
drug2439 Patient Status Engine Wiki 0.38
drug2427 Part 2 - Placebo Wiki 0.38
drug413 BMS-986253 Wiki 0.38
drug3341 TAK-981 Wiki 0.38
drug2691 Psychoeducation Wiki 0.27
drug1543 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.27
drug2556 Placebo oral capsule Wiki 0.22
drug3231 Standard of care Wiki 0.08
drug2557 Placebo oral tablet Wiki 0.07

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D009369 Neoplasms, NIH 0.21
D007239 Infection NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0001909 Leukemia HPO 0.76
HP:0002664 Neoplasm HPO 0.22

Clinical Trials

Navigate: Correlations   HPO

There are 7 clinical trials


1 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
2 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
3 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
4 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
5 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
6 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
7 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

HPO Nodes


HP:0004377: Hematological neoplasm
Genes 351
CHEK2 FANCE CBL TERT ATRX TERT RPS24 BIRC3 GATA1 STS JAK2 FANCL POT1 NOP10 TERT GATA2 RFWD3 MLH1 TCF4 LIG4 NPM1 RARA CD19 SH3GL1 CASP10 PDGFRA RPL5 BRIP1 ERBB3 RUNX1 KRAS PIGL CD81 SAMD9 THPO DYNC2LI1 RPS26 RAG2 WRAP53 CBL GFI1B STAT3 ABL1 LPP ATM TP53 IGH NRAS RPL26 RPS29 CALR ASXL1 CEBPA MALT1 ELANE CD19 TET2 NUP214 MSH2 CCND1 HAX1 SMARCD2 MYD88 EVC RAD54B RUNX1 FANCF SAMHD1 TRIP13 TNFRSF13B RUNX1 TP53 RPS10 CALR FLT3 BCL10 NRAS SETBP1 MSH2 TNFRSF13C SH2B3 FANCC BCL6 BLM CD28 LIG4 MCM4 FANCG GATA2 MYD88 GBA BCL2 GINS1 TET2 IL7R MYSM1 SLX4 KIT NBN RASGRP1 RB1 TINF2 RECQL4 FASLG PRF1 BRD4 TREX1 THPO SMPD1 FANCI NBEAL2 BUB3 ATM PDGFRB FAS FANCD2 RPS28 ZAP70 FANCA BAX LIG4 RPL11 LYST ADA CHIC2 POLE XIAP KRAS RTEL1 EVC2 XRCC2 SCN10A MPL CTLA4 ASXL1 MDM2 SAMD9L GATA2 RNASEH2B CBL JAK2 PNP UBE2T CBFB ARHGAP26 SCN11A MPL TINF2 F13A1 DCLRE1C SRP72 BCR SBDS ADA ICOS NAGS FANCB GNB1 TAL1 PIGA NUP214 TYROBP GFI1 RAD51 BCL10 TREM2 ICOS CEP57 MLH1 IGH PICALM FANCM ERCC4 FANCD2 RPS15A FANCE PIK3R1 ELANE WIPF1 IL2RG GATA1 SRP54 RAF1 LIG4 NFKB1 PTPN11 XRCC4 SRP54 TET2 TET2 PTEN EP300 CASP10 DNASE1L3 PTPN11 MS4A1 GATA2 RASGRP1 NUTM1 NTHL1 ETV6 TET2 NPM1 PIGL GFI1 RPS14 BCL10 WAS RPL18 SH2B3 RMRP SRSF2 DNMT3A DNAJC21 RPS27 RPS7 MPL FOXP1 DNMT3A CALR ASXL1 MPL TNFRSF13C TSR2 RUNX1 DKC1 APC ADAR RAD51C BRCA2 GLI1 IFIH1 SCN9A CDKN2A SH2D1A KLHDC8B NSUN2 CREBBP PGM3 SRP54 SBDS SH2B3 DNAJC21 CHD7 MPL BCR GATA2 BRCA1 BUB1B TERC CALR TNFRSF13B CD28 SAMD9L AAGAB BCR TP53 TCIRG1 ADA2 HSPA9 PIK3CA SRSF2 RNF43 TERT CR2 COL14A1 IGH RMRP FANCG IL2RG JAK2 KIF11 FLT3 JAK2 MAD2L2 FANCC RPS17 PARN NUMA1 RAD54L MSH6 RPL35 BRAF RNASEH2C CD70 SF3B1 MSH6 DDX41 TERC RECQL4 PMS2 RPL35A CCND1 BUB1 SF3B1 TERC TET2 RFWD3 CTLA4 MYC DNAJC21 TNFSF12 MAGT1 BLM FANCA KIT ITK RPL31 MLLT10 RPL15 RNASEH2A CR2 NHP2 TAL2 RPS14 NBN CD27 TCF4 NFKB2 RPS19 TNFSF12 HLA-DRB1 FAS RHOH NF1 ABL1 USB1 BUB1B NBN TET2 LIG4 PRKCD CTC1 JAK2 RPL27 PRKCD RPS19 TNFRSF1B BRCA2 DKC1 PALB2 F13B ATRX RAG1 TP63 EFL1 TNFRSF1B TET2 TET2 JAK2 KRAS
Protein Mutations 0
SNP 0

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


HP:0004377: Hematological neoplasm
Genes 351
CHEK2 FANCE CBL TERT ATRX TERT RPS24 BIRC3 GATA1 STS JAK2 FANCL POT1 NOP10 TERT GATA2 RFWD3 MLH1 TCF4 LIG4 NPM1 RARA CD19 SH3GL1 CASP10 PDGFRA RPL5 BRIP1 ERBB3 RUNX1 KRAS PIGL CD81 SAMD9 THPO DYNC2LI1 RPS26 RAG2 WRAP53 CBL GFI1B STAT3 ABL1 LPP ATM TP53 IGH NRAS RPL26 RPS29 CALR ASXL1 CEBPA MALT1 ELANE CD19 TET2 NUP214 MSH2 CCND1 HAX1 SMARCD2 MYD88 EVC RAD54B RUNX1 FANCF SAMHD1 TRIP13 TNFRSF13B RUNX1 TP53 RPS10 CALR FLT3 BCL10 NRAS SETBP1 MSH2 TNFRSF13C SH2B3 FANCC BCL6 BLM CD28 LIG4 MCM4 FANCG GATA2 MYD88 GBA BCL2 GINS1 TET2 IL7R MYSM1 SLX4 KIT NBN RASGRP1 RB1 TINF2 RECQL4 FASLG PRF1 BRD4 TREX1 THPO SMPD1 FANCI NBEAL2 BUB3 ATM PDGFRB FAS FANCD2 RPS28 ZAP70 FANCA BAX LIG4 RPL11 LYST ADA CHIC2 POLE XIAP KRAS RTEL1 EVC2 XRCC2 SCN10A MPL CTLA4 ASXL1 MDM2 SAMD9L GATA2 RNASEH2B CBL JAK2 PNP UBE2T CBFB ARHGAP26 SCN11A MPL TINF2 F13A1 DCLRE1C SRP72 BCR SBDS ADA ICOS NAGS FANCB GNB1 TAL1 PIGA NUP214 TYROBP GFI1 RAD51 BCL10 TREM2 ICOS CEP57 MLH1 IGH PICALM FANCM ERCC4 FANCD2 RPS15A FANCE PIK3R1 ELANE WIPF1 IL2RG GATA1 SRP54 RAF1 LIG4 NFKB1 PTPN11 XRCC4 SRP54 TET2 TET2 PTEN EP300 CASP10 DNASE1L3 PTPN11 MS4A1 GATA2 RASGRP1 NUTM1 NTHL1 ETV6 TET2 NPM1 PIGL GFI1 RPS14 BCL10 WAS RPL18 SH2B3 RMRP SRSF2 DNMT3A DNAJC21 RPS27 RPS7 MPL FOXP1 DNMT3A CALR ASXL1 MPL TNFRSF13C TSR2 RUNX1 DKC1 APC ADAR RAD51C BRCA2 GLI1 IFIH1 SCN9A CDKN2A SH2D1A KLHDC8B NSUN2 CREBBP PGM3 SRP54 SBDS SH2B3 DNAJC21 CHD7 MPL BCR GATA2 BRCA1 BUB1B TERC CALR TNFRSF13B CD28 SAMD9L AAGAB BCR TP53 TCIRG1 ADA2 HSPA9 PIK3CA SRSF2 RNF43 TERT CR2 COL14A1 IGH RMRP FANCG IL2RG JAK2 KIF11 FLT3 JAK2 MAD2L2 FANCC RPS17 PARN NUMA1 RAD54L MSH6 RPL35 BRAF RNASEH2C CD70 SF3B1 MSH6 DDX41 TERC RECQL4 PMS2 RPL35A CCND1 BUB1 SF3B1 TERC TET2 RFWD3 CTLA4 MYC DNAJC21 TNFSF12 MAGT1 BLM FANCA KIT ITK RPL31 MLLT10 RPL15 RNASEH2A CR2 NHP2 TAL2 RPS14 NBN CD27 TCF4 NFKB2 RPS19 TNFSF12 HLA-DRB1 FAS RHOH NF1 ABL1 USB1 BUB1B NBN TET2 LIG4 PRKCD CTC1 JAK2 RPL27 PRKCD RPS19 TNFRSF1B BRCA2 DKC1 PALB2 F13B ATRX RAG1 TP63 EFL1 TNFRSF1B TET2 TET2 JAK2 KRAS
Protein Mutations 0
SNP 0

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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4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

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263 reports on HPO terms

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Alphabetical index of all Terms

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