Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: * To evaluate the safety profile of isatuximab. * To evaluate the duration of response (DOR). * To evaluate progression free survival (PFS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. * To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. * To assess minimal residual disease (MRD) and correlate it with clinical outcome.
The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:pills Route of administration: oral
Pharmaceutical form:solution Route of administration: intravenous
Investigational Site Number 8400002
Atlanta, Georgia, United States
Investigational Site Number 8400003
Hackensack, New Jersey, United States
Percentage of Participants With Objective Response
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.
Time frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Duration of Response (DOR)
DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. Progressive disease as per NCCN guidelines was defined as increase of at least 25 percentage (%) in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Time frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Progression Free Survival (PFS)
PFS was defined as the time interval (in days) from the date of first study drug administration to the date of first observation of PD or death due to any cause, whichever came first. PD as per NCCN guidelines was defined as increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.
Time frame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Overall Survival (OS)
Overall Survival was defined as the time interval from the date of first study drug administration to the date of death due to any cause.
Time frame: Baseline until death (maximum duration: 12.1 weeks)
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Pharmaceutical form:pills Route of administration: oral
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:solution Route of administration: intravenous
Investigational Site Number 8400001
Houston, Texas, United States
Investigational Site Number 2460001
Helsinki, Finland
Investigational Site Number 2500005
Nantes, France
Investigational Site Number 2500001
Paris, France
Investigational Site Number 2500004
Pessac, France
Investigational Site Number 2500002
Pierre-Bénite, France
Investigational Site Number 3480001
Budapest, Hungary
Investigational Site Number 3480003
Budapest, Hungary
...and 7 more locations
Number of Participants With Minimal Residual Disease (MRD)
Presence of MRD was measured by sequencing and/or flow cytometry in participants achieving CR and CRi. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, ANC greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. Complete response with incomplete blood count recovery meet all criteria for complete response except platelet count and/or ANC.
Time frame: Baseline until death or study cut-off (maximum duration: 12.1 weeks)