Covid 19 Research using Clinical Trials (Home Page)
Report for D054198: Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH
(Synonyms: Precursor Cell Lym, Precursor Cell Lymph, Precursor Cell Lympho, Precursor Cell Lymphob, Precursor Cell Lymphobl, Precursor Cell Lymphoblast, Precursor Cell Lymphoblastic L, Precursor Cell Lymphoblastic Le, Precursor Cell Lymphoblastic Leuk, Precursor Cell Lymphoblastic Leukem, Precursor Cell Lymphoblastic Leukemia, Precursor Cell Lymphoblastic Leukemia-, Precursor Cell Lymphoblastic Leukemia-L, Precursor Cell Lymphoblastic Leukemia-Lym, Precursor Cell Lymphoblastic Leukemia-Lymp, Precursor Cell Lymphoblastic Leukemia-Lymph, Precursor Cell Lymphoblastic Leukemia-Lymphoma)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007938 | Leukemia, NIH | 0.71 |
| D007945 | Leukemia, Lymphoid NIH | 0.50 |
| D015470 | Leukemia, Myeloid, Acute NIH | 0.50 |
| D008223 | Lymphoma, NIH | 0.32 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004808 | Acute myeloid leukemia HPO | 0.50 |
| HP:0005526 | Lymphoid leukemia HPO | 0.50 |
| HP:0001909 | Leukemia HPO | 0.43 |
| HP:0002665 | Lymphoma HPO | 0.32 |
There are 2 clinical trials
Clinical Trials
1 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
The 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
2 National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
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 COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.
NCT04452604 Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia SARS-CoV-2 MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia
Primary Outcomes
Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Measure: Clinical prognostic factors for infection with COVID-19 Time: Day 0
Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
Measure: Biological prognostic factors for infection with COVID-19 Time: Day 0
Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis
HPO Nodes
Primary Outcomes
Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Measure: Clinical prognostic factors for infection with COVID-19 Time: Day 0Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
Measure: Biological prognostic factors for infection with COVID-19 Time: Day 0Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis