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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
drug338 Azithromycin 250 MG Oral Capsule Wiki 0.38
drug2366 Part 1 - TL-895 Wiki 0.38
drug2368 Part 2 - TL-895 Wiki 0.38
Name (Synonyms) Correlation
drug2670 Quality of life assessment Wiki 0.38
drug2380 Patient Status Engine Wiki 0.38
drug2367 Part 2 - Placebo Wiki 0.38
drug374 BMS-986253 Wiki 0.38
drug3248 TAK-981 Wiki 0.38
drug1293 Flow cytometric analysis Wiki 0.27
drug1497 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.27
drug2512 Placebo oral capsule Wiki 0.22
drug3146 Standard of care Wiki 0.07
drug2514 Placebo oral tablet Wiki 0.07

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D009369 Neoplasms, NIH 0.28
D007239 Infection NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0001909 Leukemia HPO 0.84
HP:0002664 Neoplasm HPO 0.28

Clinical Trials

Navigate: Correlations   HPO

There are 7 clinical trials


1 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability, Preliminary Efficacy 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 determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed/refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 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: Phase 1: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Time: Up to 48 months

Description: Severity grade will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which will be assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.

Measure: Phase 1: Number of Participants Based on Severity of TEAEs

Time: Up to 48 months

Measure: Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Time: Up to Cycle 1 (Cycle length is equal to [=] 21 days)

Measure: Phase 1: Number of Participants With Clinically Significant Laboratory Values

Time: Up to 48 months

Description: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR), 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 or Lugano classification for lymphoma.

Measure: Phase 2: Overall Response Rate (ORR)

Time: From the first dose until best response is achieved (up to 4 years)

Measure: COVID-19 Expansion: Number of Participants With Greater Than or Equal to (>=) 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: Phase 2: Number of Participants Reporting one or More TEAEs

Time: Up to 48 months

Description: Severity grade will be evaluated as per the NCI CTCAE Version 5.0, except for CRS, which will be assessed by ASTCT consensus grading criteria.

Measure: Phase 2: Number of Participants Based on Severity of TEAEs

Time: Up to 48 months

Measure: Phase 2, 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: Phase 2, 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: Phase 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable 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 =21 days)

Measure: Phase 2, 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: Phase 2, 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: Phase 2, Total Clearance (CL) After Intravenous Administration 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: Phase 2, 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 CR and PR through the study (approximately 4 years), as determined by the investigator according to the RECIST V1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: ORR

Time: From the first dose until best response is achieved (up to 4 years)

Description: DOR is the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease for responders (PR or better) and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: 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 4 years)

Description: DCR is defined as the percentage of participants who achieve stable disease (SD) or better (determined by the investigator according to RECIST v1.1 criteria for solid tumors or Lugano classification for lymphoma) greater than (>) 6 weeks during the study in the response-evaluable population.

Measure: Phase 2: Disease Control Rate (DCR)

Time: From the first dose until best response is achieved (up to 4 years)

Description: TTR is defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Time to Response (TTR)

Time: From the date of first study drug administration to the date of first documented PR or better (up to 4 years)

Description: TTP is defined as the time from the date of the first dose administration to the date of first documented progressive disease and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Time to Progression (TTP)

Time: From the date of first study drug administration to the date of first documented PD (up to 4 years)

Description: PFS is defined as the time from the date of the first dose administration to the date of first documentation of progressive disease or death due to any cause, whichever occurs first and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: 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 4 years)

Description: OS is defined as the time from the date of the first dose administration to the date of death.

Measure: Phase 2: Overall Survival (OS)

Time: From the date of first study drug administration to the date of death (up to 4 years)

Measure: Phase 2: Number of Participants With TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation and SUMO Pathway Inhibition in Skin/Blood

Time: Up to 48 months

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: Duration of TEAEs

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 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
5 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
6 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
7 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


HP:0004377: Hematological neoplasm
Genes 350
CHD7 GFI1B FANCG NSUN2 RPS7 DNAJC21 NAGS SH3GL1 IGH SRP54 MS4A1 GATA2 TINF2 F13B COL14A1 CD19 DYNC2LI1 NUMA1 ELANE RPS26 PIGA CTPS1 APC HSPA9 POLE RPS17 APC2 CDKN2A FANCM RPS15A PIGL DDX41 RAG2 CBFB MALT1 BCL10 PIGL NSD1 GLI1 CD70 PGM3 SH2B3 BAX GATA1 ATM FANCE MPL TP53 BUB1 TET2 PALB2 KLHDC8B TNFSF12 RARA MLH1 GINS1 RAD51C EVC BUB1B FANCE WIPF1 RUNX1 PDGFRA MYD88 IGH TNFRSF1B ETV6 MDM2 TP63 FANCD2 NBEAL2 RNASEH2C SAMD9L NF1 DNMT3A CBL LPP FANCC TP53 BRIP1 GATA2 CD19 ASXL1 NRAS PICALM CD81 SF3B1 TNFRSF13B SMPD1 SMARCD2 BRCA1 TYROBP MPL LIG4 ABL1 MYD88 ATM RPS10 ATRX FANCG ASXL1 TET2 NUTM1 BCR FLT3 KRAS SRP72 MPL RPL27 EVC2 CBL CD28 BRCA2 SRSF2 XRCC4 RAF1 RPL11 THPO FASLG NOP10 CHEK2 SRSF2 CREBBP BUB1B TET2 PRKCD CALR GATA2 DNMT3A LIG4 BLM BCL2 FOXP1 TNFRSF13C TERT SF3B1 RPL15 TERC ADA2 PDGFRB TERT RPS14 TNFRSF1B FANCD2 RTEL1 RUNX1 IL7R USB1 SCN9A RASGRP1 CR2 IGH POT1 JAK2 NBN NRAS LIG4 TCF4 DNAJC21 MAD2L2 SH2D1A NTHL1 RPL35 FANCL KRAS ADA FAS CHIC2 STAT3 SETBP1 PGM3 CALR FANCB TAL2 PIK3R1 STAT3 PNP SAMD9L TET2 MLLT10 ICOS BRD4 NUP214 SLX4 LIG4 NBN NUP214 DCLRE1C JAK2 AAGAB BLM RECQL4 RAG1 CCND1 RPL31 MSH2 MCM4 TREX1 TINF2 ZAP70 MAGT1 GATA2 BCR MPL TNFRSF13B TET2 IFIH1 ASXL1 WAS CR2 SAMD9 RPL5 KIT RPS27 RMRP RPS24 WRAP53 FANCF RPL35A FAS SAMHD1 TP53 MLH1 TET2 PTEN PIK3CA TCIRG1 UBE2T SRP54 RPS19 DKC1 JAK2 RPS14 CASP10 FLT3 SRP54 JAK2 RMRP TNFRSF13C NFKB1 RPL18 TERT RUNX1 MYC DNAJC21 RECQL4 SBDS CCND1 KIF11 BIRC3 NFKB2 GFI1 CD27 ADA RNASEH2B BCL10 RNF43 KRAS SETD2 FANCC ERCC4 CTLA4 BCL6 GBA RAD51 TREM2 JAK2 TERT NBN BRAF XRCC2 FANCI ITK CALR GATA1 CD28 CTC1 ADA2 PTPN11 TSR2 JAK2 HLA-DRB1 TET2 CEP57 NPM1 CTLA4 ADAR RFWD3 SBDS ICOS EFL1 TERC BUB3 KIT EP300 RNASEH2A IL2RG F13A1 TRIP13 LIG4 PARN RHOH MPL DNASE1L3 RASGRP1 ATRX NF1 RFWD3 FANCA STS PRKCD DKC1 SCN10A PTPN11 RPS19 RPS29 RPL26 ABL1 HAX1 LRBA ELANE FANCA NHP2 NPM1 RUNX1 PRKCD ANAPC1 TERC SCN11A CEBPA TCF4 GATA2 IL2RG RB1 GNB1 CBL BRCA2 SH2B3 BCR MSH6 ARHGAP26 TET2 TAL1 GFI1 TNFSF12 RPS28 MYSM1 XIAP ERBB3 TET2
Protein Mutations 0
SNP 0

HPO

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


HPO Nodes


HP:0004377: Hematological neoplasm
Genes 350
CHD7 GFI1B FANCG NSUN2 RPS7 DNAJC21 NAGS SH3GL1 IGH SRP54 MS4A1 GATA2 TINF2 F13B COL14A1 CD19 DYNC2LI1 NUMA1 ELANE RPS26 PIGA CTPS1 APC HSPA9 POLE RPS17 APC2 CDKN2A FANCM RPS15A PIGL DDX41 RAG2 CBFB MALT1 BCL10 PIGL NSD1 GLI1 CD70 PGM3 SH2B3 BAX GATA1 ATM FANCE MPL TP53 BUB1 TET2 PALB2 KLHDC8B TNFSF12 RARA MLH1 GINS1 RAD51C EVC BUB1B FANCE WIPF1 RUNX1 PDGFRA MYD88 IGH TNFRSF1B ETV6 MDM2 TP63 FANCD2 NBEAL2 RNASEH2C SAMD9L NF1 DNMT3A CBL LPP FANCC TP53 BRIP1 GATA2 CD19 ASXL1 NRAS PICALM CD81 SF3B1 TNFRSF13B SMPD1 SMARCD2 BRCA1 TYROBP MPL LIG4 ABL1 MYD88 ATM RPS10 ATRX FANCG ASXL1 TET2 NUTM1 BCR FLT3 KRAS SRP72 MPL RPL27 EVC2 CBL CD28 BRCA2 SRSF2 XRCC4 RAF1 RPL11 THPO FASLG NOP10 CHEK2 SRSF2 CREBBP BUB1B TET2 PRKCD CALR GATA2 DNMT3A LIG4 BLM BCL2 FOXP1 TNFRSF13C TERT SF3B1 RPL15 TERC ADA2 PDGFRB TERT RPS14 TNFRSF1B FANCD2 RTEL1 RUNX1 IL7R USB1 SCN9A RASGRP1 CR2 IGH POT1 JAK2 NBN NRAS LIG4 TCF4 DNAJC21 MAD2L2 SH2D1A NTHL1 RPL35 FANCL KRAS ADA FAS CHIC2 STAT3 SETBP1 PGM3 CALR FANCB TAL2 PIK3R1 STAT3 PNP SAMD9L TET2 MLLT10 ICOS BRD4 NUP214 SLX4 LIG4 NBN NUP214 DCLRE1C JAK2 AAGAB BLM RECQL4 RAG1 CCND1 RPL31 MSH2 MCM4 TREX1 TINF2 ZAP70 MAGT1 GATA2 BCR MPL TNFRSF13B TET2 IFIH1 ASXL1 WAS CR2 SAMD9 RPL5 KIT RPS27 RMRP RPS24 WRAP53 FANCF RPL35A FAS SAMHD1 TP53 MLH1 TET2 PTEN PIK3CA TCIRG1 UBE2T SRP54 RPS19 DKC1 JAK2 RPS14 CASP10 FLT3 SRP54 JAK2 RMRP TNFRSF13C NFKB1 RPL18 TERT RUNX1 MYC DNAJC21 RECQL4 SBDS CCND1 KIF11 BIRC3 NFKB2 GFI1 CD27 ADA RNASEH2B BCL10 RNF43 KRAS SETD2 FANCC ERCC4 CTLA4 BCL6 GBA RAD51 TREM2 JAK2 TERT NBN BRAF XRCC2 FANCI ITK CALR GATA1 CD28 CTC1 ADA2 PTPN11 TSR2 JAK2 HLA-DRB1 TET2 CEP57 NPM1 CTLA4 ADAR RFWD3 SBDS ICOS EFL1 TERC BUB3 KIT EP300 RNASEH2A IL2RG F13A1 TRIP13 LIG4 PARN RHOH MPL DNASE1L3 RASGRP1 ATRX NF1 RFWD3 FANCA STS PRKCD DKC1 SCN10A PTPN11 RPS19 RPS29 RPL26 ABL1 HAX1 LRBA ELANE FANCA NHP2 NPM1 RUNX1 PRKCD ANAPC1 TERC SCN11A CEBPA TCF4 GATA2 IL2RG RB1 GNB1 CBL BRCA2 SH2B3 BCR MSH6 ARHGAP26 TET2 TAL1 GFI1 TNFSF12 RPS28 MYSM1 XIAP ERBB3 TET2
Protein Mutations 0
SNP 0

Reports

Data processed on December 13, 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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Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

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Alphabetical index of all Terms

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