Covid 19 Research using Clinical Trials (Home Page)
Report for D019337: Hematologic Neoplasms NIH
(Synonyms: Hematologic Ne, Hematologic Neo, Hematologic Neopla, Hematologic Neoplasm, Hematologic Neoplasms)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug110 | Azithromycin 250 MG Oral Capsule Wiki | 0.45 |
| drug825 | Patient Status Engine Wiki | 0.45 |
| drug695 | Mesenchymal cells Wiki | 0.45 |
| drug129 | BMS-986253 Wiki | 0.45 |
| drug1116 | TAK-981 Wiki | 0.45 |
| drug864 | Placebo oral capsule Wiki | 0.32 |
| drug527 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.26 |
| drug1067 | Standard of care Wiki | 0.13 |
| drug865 | Placebo oral tablet Wiki | 0.09 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009369 | Neoplasms, NIH | 0.40 |
| D007239 | Infection NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001909 | Leukemia HPO | 0.91 |
| HP:0002664 | Neoplasm HPO | 0.40 |
There are 5 clinical trials
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 Neoplasms Lymphoma Hematologic Neoplasms Coronavirus Disease Drug: TAK-981 Drug: Standard of care MeSH:Coronavirus Infections Hematologic Neoplasms 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
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 monthsMeasure: 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 monthsMeasure: 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 monthsMeasure: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsMeasure: 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 monthsDescription: 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 monthsMeasure: 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
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 Solid Tumor Sars-CoV2 Hematological Malignancy 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
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 yearSecondary 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 yearDescription: 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 yearDescription: 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 yearDescription: 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 monthThis 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 SARS-CoV-2 Infection Hematological Malignancies MeSH:Infection Hematologic Neoplasms 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
Primary Outcomes
Description: The percentage of HM patients with COVID-19 who died.
Measure: To evaluate mortality. Time: At 2 months from study initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationSecondary 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationMeasure: Viral dynamics in infected HM patients Time: At 12 months from study initiation
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 COVID19 Hematologic Malignancy Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Azithromycin 250 MG Oral Capsule Drug: Placebo oral tablet Drug: Placebo oral capsule MeSH:Hematologic Neoplasms 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.
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 treatmentSecondary 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 monthsDescription: 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 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: 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 10Description: 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 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: 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 treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: 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 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: 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 treatmentSince 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 COVID Oncology Haematological Malignancy 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
HPO Nodes
HP:0001909: Leukemia
Genes 187
BLM KRAS PDGFRA RB1 SH2B3 SRP54 NPM1 HAX1 TET2 FLT3 FANCC SMPD1 GFI1 RPS15A GATA1 KIT RPL11 RUNX1 RPS19 RPL35A CALR ATRX MSH2 NF1 SAMD9L TRIP13 EVC2 PIGA GATA2 TSR2 SAMD9L SPINK1 DDX41 FANCD2 ATM NRAS MLLT10 ADA2 BUB1 SH2B3 RPS29 MPL CEBPA RUNX1 ASXL1 TP53 CALR SETBP1 RNASEH2B NUP214 JAK2 SBDS WAS THPO TREM2 STS RPS24 TERT KIT JAK2 BLM BCR SRP54 SRP54 MLH1 RNASEH2C RPL18 MYD88 ELANE SH2B3 CBL GLI1 TYROBP FANCE DKC1 GATA2 DNAJC21 RPL15 KIF11 CALR TP53 SRSF2 MPL GATA2 IFIH1 SCN11A RPS10 TREX1 DNMT3A CTRC RPS27 LIG4 RPS26 FANCG SF3B1 ELANE SAMHD1 TET2 NBN NUP214 ETV6 PICALM RNASEH2A DNAJC21 JAK2 BUB3 TCIRG1 BCR BUB1B RPS28 FANCA RPL5 DYNC2LI1 NBN DNMT3A DNAJC21 MSH6 RARA PIK3CA TERC MYD88 BUB1B ARHGAP26 KRAS RPS7 RUNX1 RPL35 LPP BRCA2 CBL BRD4 GNB1 PIK3R1 CBFB ADAR F13A1 SBDS TAL1 EFL1 RPS17 JAK2 FLT3 RPS14 BCR CEP57 POT1 KRAS ABL1 APC ABL1 PMS2 TET2 WIPF1 JAK2 GATA1 NSUN2 LIG4 SH3GL1 XRCC4 F13B RPL26 RPL31 MPL PTPN11 PDGFRB NUTM1 TAL2 PIGL PIGL PRSS1 TET2 RPL27 EP300 NRAS CHIC2 TET2 GATA2 NUMA1 TERT GFI1 MPL THPO CREBBP SCN10A SCN9A ERBB3 EVC Protein Mutations 56
C282Y C481S D816V D835Y E255K E255V F317C F317L F317S F317V F31I F359C F359V G250E G71R H369P H63D L248R L248V L265P L858R N291S N682S P13K P140K P1446A P4503A Q12H Q252H R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W S1612C S9333A T315A T315I T351I T790M V158M V299L V57I V600E V617F V66M Y253H HP:0004377: Hematological neoplasm
Genes 347
KRAS PDGFRA IL2RG SRP54 IL2RG NPM1 TET2 FLT3 ITK SMPD1 PRKCD GATA1 KIT RPL11 RUNX1 CALR ATRX TNFRSF1B DCLRE1C SAMD9L EVC2 CD70 BRAF TSR2 SPINK1 RNF43 FASLG ATM CASP10 NRAS BCL10 BUB1 SH2B3 RPS29 CEBPA TP53 CHD7 TINF2 MYSM1 ASXL1 UBE2T CR2 CALR SETBP1 RNASEH2B KLHDC8B MALT1 TINF2 RAF1 STS TERT BCR SRP54 SRP54 TNFSF12 MLH1 RPL18 ELANE DNASE1L3 CBL MAGT1 TYROBP ASXL1 FOXP1 IL7R TCF4 FANCE DNAJC21 RPL15 FANCL KIF11 TP53 COL14A1 MPL HSPA9 IFIH1 SCN11A RPS10 JAK2 DNMT3A CTRC BCL2 LIG4 GINS1 TERC FANCG SF3B1 ELANE NBN NHP2 NUP214 MYC ETV6 CD81 TNFSF12 RNASEH2A BRIP1 BCR BUB1B RPL5 NBN FANCF IGH DNAJC21 TNFRSF1B CCND1 RMRP XRCC2 MSH6 FAS IGH NFKB2 RECQL4 CD28 BUB1B CTLA4 ARHGAP26 RPL35 CBL RAD54L POLE PALB2 GNB1 MDM2 CBFB ADAR ADA RPS17 PARN RPS14 BCR POT1 ABL1 TNFRSF13C FANCE TNFRSF13B ABL1 ICOS TET2 CD27 NFKB1 CALR LIG4 SH3GL1 CD28 PNP F13B USB1 RPL26 RPL31 PTPN11 TP63 RAD51 MPL TET2 PTPN11 ADA NUTM1 STAT3 RAG2 PIGL PRSS1 TET2 NRAS PRF1 FANCA GFI1 ATRX FANCD2 SCN9A TET2 EVC TNFRSF13C BLM RB1 FANCM SH2B3 RTEL1 HAX1 FANCC RAD54B BIRC3 GFI1 RPS15A RPS14 GFI1B RPS19 RPL35A MSH2 TCF4 RFWD3 NF1 TRIP13 PIGA GATA2 ATM SAMD9L DDX41 IGH FANCD2 RASGRP1 CASP10 MLLT10 ADA2 LIG4 MPL RUNX1 BRCA2 CD19 ERCC4 TP53 RMRP RAD51C NUP214 JAK2 SBDS SH2D1A WAS SMARCD2 THPO ZAP70 TREM2 RPS24 KIT JAK2 BLM BRCA1 RNASEH2C MYD88 RFWD3 SAMD9 SLX4 TNFRSF13B SH2B3 GLI1 CHEK2 NPM1 TET2 DKC1 GATA2 MS4A1 ICOS CALR RPS19 DKC1 LIG4 SRSF2 CR2 GATA2 RAG1 PRKCD BCL6 TREX1 RPS27 RPS26 FANCG GBA FANCI LYST SAMHD1 TET2 GATA2 LIG4 PICALM DNAJC21 NTHL1 JAK2 BUB3 TCIRG1 RPS28 FANCA MPL DYNC2LI1 DNMT3A AAGAB FANCC RARA PIK3CA TERC PGM3 MAD2L2 MYD88 MLH1 FANCB MSH6 KRAS TERT RPS7 RUNX1 MCM4 BCL10 XIAP LPP BRCA2 CD19 BRD4 PIK3R1 PTEN NAGS NBEAL2 F13A1 CTC1 SBDS HLA-DRB1 WRAP53 TAL1 EFL1 NOP10 JAK2 FLT3 CEP57 KRAS APC PMS2 WIPF1 JAK2 TERC CTLA4 GATA1 NSUN2 BCL10 XRCC4 NBN SF3B1 FAS PDGFRB RHOH MSH2 RECQL4 TAL2 PIGL RPL27 EP300 CHIC2 CCND1 TET2 GATA2 NUMA1 TERT MPL THPO CREBBP SCN10A CDKN2A ERBB3 SRP72 TERT Protein Mutations 0
SNP 0
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 weeksDescription: 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 devicesSecondary 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 weeksDescription: Device tolerability as assessed by semi-structured interviews.
Measure: Device Tolerability (Semi-structured interviews) Time: One to four weeks after completion of wearing the deviceDescription: 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