CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D007945: Leukemia, Lymphoid NIH

(Synonyms: Leukemia, L, Leukemia, Ly, Leukemia, Lym, Leukemia, Lymp, Leukemia, Lymph, Leukemia, Lympho, Leukemia, Lymphoc, Leukemia, Lymphocy, Leukemia, Lymphocyt, Leukemia, Lymphocytic, Leukemia, Lymphocytic,, Leukemia, Lymphocytic,, Leukemia, Lymphoid)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug848 Data registry Wiki 0.71
drug1505 Ixazomib Wiki 0.50

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D007938 Leukemia, NIH 0.71
D010007 Osteochondritis NIH 0.71
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.71
D008223 Lymphoma, NIH 0.63
D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.50

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0005526 Lymphoid leukemia HPO 1.00
HP:0005550 Chronic lymphatic leukemia HPO 0.71
HP:0002665 Lymphoma HPO 0.63
HP:0001909 Leukemia HPO 0.43

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 Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

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