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 (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3097 | Voraxaze Wiki | 0.45 |
| drug601 | Camidanlumab Tesirine Wiki | 0.45 |
| drug2457 | Rituximab Wiki | 0.45 |
| drug3319 | leucovorin Wiki | 0.45 |
| drug848 | Data registry Wiki | 0.45 |
| drug1505 | Ixazomib Wiki | 0.32 |
| drug1740 | Methotrexate Wiki | 0.22 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008223 | Lymphoma, NIH | 1.00 |
| D007945 | Leukemia, Lymphoid NIH | 0.63 |
| D006689 | Hodgkin Disease NIH | 0.45 |
| D007938 | Leukemia, NIH | 0.45 |
| D010007 | Osteochondritis NIH | 0.45 |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell NIH | 0.45 |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH | 0.32 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005526 | Lymphoid leukemia HPO | 0.63 |
| HP:0005550 | Chronic lymphatic leukemia HPO | 0.45 |
| HP:0012189 | Hodgkin lymphoma HPO | 0.45 |
| HP:0001909 | Leukemia HPO | 0.27 |
There are 5 clinical trials
Clinical Trials
1 LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL.
NCT03684980 Central Nervous System Lymphoma Drug: Voraxaze Drug: Methotrexate Drug: Rituximab Drug: leucovorin MeSH:Lymphoma
HPO:Lymphoma
Primary Outcomes
Description: All serum samples will be tested via MTX immunoassay (measures MTX levels in addition to byproducts) as well as HPLC or mass spectroscopy which will reveal plasma concentrations of MTX and DAMPA separately.
Measure: number of patients that have significant reduction of serum methotrexate levels Time: 1 year
2 Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma
Primary Outcomes
Description: All serum samples will be tested via MTX immunoassay (measures MTX levels in addition to byproducts) as well as HPLC or mass spectroscopy which will reveal plasma concentrations of MTX and DAMPA separately.
Measure: number of patients that have significant reduction of serum methotrexate levels Time: 1 yearThe purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.
NCT03888534 Precursor Cell Lymphoblastic Leukemia-lymphoma Drug: Ixazomib MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia Lymphoma
Primary Outcomes
Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy Time: Up to Day 29
Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Time: Up to 30 months
Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters Time: Up to 30 months
Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Secondary Outcomes
Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measure: Overall Response Rate (ORR) Time: Up to 30 months
3 A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Primary Outcomes
Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy Time: Up to Day 29Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Time: Up to 30 months
Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters Time: Up to 30 months
Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Secondary Outcomes
Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measure: Overall Response Rate (ORR) Time: Up to 30 monthsThe purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
NCT04052997 Relapsed Hodgkin Lymphoma Refractory Hodgkin Lymphoma Drug: Camidanlumab Tesirine MeSH:Lymphoma Hodgkin Disease
HPO:Hodgkin lymphoma Lymphoma
Primary Outcomes
Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 3 years
Secondary Outcomes
Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.
Measure: Duration of Response (DOR) Time: Up to 3 years
Description: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Measure: Complete Response (CR) Rate Time: Up to 3 years
Description: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.
Measure: Relapse-Free Survival (RFS) Time: Up to 3 years
Description: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Measure: Progression-Free Survival (PFS) Time: Up to 3 years
Description: OS defined as the time from first dose of study drug until death due to any cause.
Measure: Overall Survival (OS) Time: Up to 3 years
Measure: Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT) Time: Up to 3 years
Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.
Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: An SAE is defined as any adverse event (AE) that:
results in death.
is life threatening.
requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE).
results in persistent or significant disability/incapacity.
is a congenital anomaly/birth defect.
important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab Tesirine
Measure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With At Least One ADA Titer Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.
Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.
Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
4 Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique
Primary Outcomes
Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 3 yearsSecondary Outcomes
Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.
Measure: Duration of Response (DOR) Time: Up to 3 yearsDescription: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Measure: Complete Response (CR) Rate Time: Up to 3 yearsDescription: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.
Measure: Relapse-Free Survival (RFS) Time: Up to 3 yearsDescription: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Measure: Progression-Free Survival (PFS) Time: Up to 3 yearsDescription: OS defined as the time from first dose of study drug until death due to any cause.
Measure: Overall Survival (OS) Time: Up to 3 yearsMeasure: Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT) Time: Up to 3 years
Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.
Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) Time: Day 1 (post-dose) until 30 days after last dose of study drugDescription: An SAE is defined as any adverse event (AE) that: results in death. is life threatening. requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE). results in persistent or significant disability/incapacity. is a congenital anomaly/birth defect. important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE) Time: Day 1 (post-dose) until 30 days after last dose of study drugDescription: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab Tesirine
Measure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drugMeasure: Number of Participants With At Least One ADA Titer Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.
Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.
Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20). The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma. Translated with www.DeepL.com/Translator (free version)
NCT04386512 COVID Lymphoma MeSH:Lymphoma
HPO:Lymphoma
Primary Outcomes
Measure: mortality Time: 2 months
Measure: transfer to ICU Time: 2 months
5 National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
Primary Outcomes
Measure: mortality Time: 2 monthsMeasure: transfer to ICU Time: 2 months
The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012. Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.
NCT04391946 Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease Behavioral: Data registry MeSH:Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Osteochondritis
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma
Primary Outcomes
Description: Hematological pathology Description
Measure: Prognostic factors for healing of COVID-19 infection Time: Day 0
Secondary Outcomes
Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis
Description: Allow national epidemiological monitoring and regularly inform the hematology community.
Measure: national epidemiological monitoring Time: through study completion, an average of 2 years
HPO Nodes
HP:0002665: Lymphoma
Genes 135
CHEK2 CBL ICOS IGH BIRC3 PIK3R1 WIPF1 IL2RG LIG4 NOP10 NFKB1 MLH1 XRCC4 TCF4 TET2 PTEN LIG4 CD19 CASP10 CASP10 DNASE1L3 MS4A1 RASGRP1 NTHL1 NPM1 CD81 RAG2 WRAP53 BCL10 WAS STAT3 RMRP ATM SRSF2 IGH FOXP1 ASXL1 TNFRSF13C MALT1 CD19 DKC1 APC CCND1 MYD88 RAD54B CDKN2A RUNX1 SH2D1A KLHDC8B NSUN2 PGM3 TNFRSF13B RUNX1 CHD7 TERC TNFRSF13B BCL10 CD28 NRAS MSH2 TNFRSF13C AAGAB TP53 BCL6 BLM SRSF2 RNF43 TERT CR2 CD28 LIG4 COL14A1 IGH RMRP IL2RG MYD88 BCL2 KIF11 TET2 IL7R KIT RASGRP1 RB1 PARN RECQL4 FASLG RAD54L PRF1 ATM FAS MSH6 DDX41 ZAP70 PMS2 CTLA4 MYC LYST ADA POLE TNFSF12 MAGT1 BLM ITK CR2 XIAP NHP2 RTEL1 NBN CD27 TCF4 NFKB2 CTLA4 TNFSF12 ASXL1 MDM2 HLA-DRB1 FAS RHOH PNP USB1 NBN PRKCD TINF2 CTC1 DCLRE1C PRKCD TNFRSF1B DKC1 ADA ICOS RAG1 TP63 TNFRSF1B BCL10 KRAS 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
Description: Hematological pathology Description
Measure: Prognostic factors for healing of COVID-19 infection Time: Day 0Secondary Outcomes
Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosisDescription: Allow national epidemiological monitoring and regularly inform the hematology community.
Measure: national epidemiological monitoring Time: through study completion, an average of 2 years