Covid 19 Research using Clinical Trials (Home Page)
HP:0002665: LymphomaHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug512 | Mindfulness-based "STOP touching your face" practice Wiki | 1.00 |
| drug812 | TAK-981 Wiki | 1.00 |
| drug775 | Standard of care Wiki | 0.35 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D019337 | Hematologic Neoplasms NIH | 0.58 |
| D009369 | Neoplasms, NIH | 0.38 |
| D018352 | Coronavirus Infections NIH | 0.06 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
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
HPO Nodes
HP:0002665: Lymphoma
Genes 133
ATM KRAS CD19 IGH DDX41 BCL10 BIRC3 FOXP1 MS4A1 TP63 RAG1 LIG4 NFKB2 MSH6 TERC RECQL4 NTHL1 WIPF1 CTC1 LYST NOP10 RASGRP1 TNFRSF1B XRCC4 PRKCD NHP2 MAGT1 TNFRSF13B IGH RMRP RUNX1 CTLA4 DCLRE1C FAS ICOS RNF43 NSUN2 XIAP IL7R CASP10 BCL6 CDKN2A ATM IL2RG RTEL1 PARN NBN KIT TNFRSF13C TCF4 ICOS TNFSF12 CHEK2 USB1 CD19 CR2 NRAS MSH2 WAS BCL10 CASP10 MYD88 COL14A1 PRKCD TNFRSF13B MYC MDM2 SH2D1A CCND1 BCL10 CFTR CD27 PGM3 TCF4 CHD7 IGH LIG4 BLM BCL2 TET2 HLA-DRB1 PRSS1 NPM1 KIF11 ITK WRAP53 RAD54B TINF2 FAS DKC1 APC CD81 LIG4 BLM CD28 DKC1 AAGAB RAG2 TNFRSF1B MLH1 TNFRSF13C DNASE1L3 NFKB1 PMS2 ASXL1 IL2RG PRF1 PTEN MALT1 RAD54L CTLA4 CD28 PNP SRSF2 TNFSF12 STAT3 POLE ADA CR2 ADA FASLG PIK3R1 TP53 CTRC ZAP70 MYD88 RB1 RMRP SPINK1 TERT KLHDC8B NBN RHOH Protein Mutations 52
A677G A677V A687V C282Y C481S E571K F1174L G156A G71R H1112L H1112Y H1124D H63D I10A I1171N L1213V L265P M1149T M1268T P1009S P11A P13K P140K P4503A Q12H Q21D Q28D R131H R988C T1010I T1191I T315I T351I T790M V1110L V1206L V1238I V158F V158M V600E V617F V66M V941L Y1248C Y1248D Y1248H Y1253D Y641C Y641F Y641H Y641N Y641S
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