Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
- Conditions
- T-lymphoblastic Lymphoma/LeukaemiaT-cell Type Acute Leukemia-Precursor
- Interventions
- Registration Number
- NCT02999633
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Isatuximab Isatuximab SAR650984 Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Isatuximab acetaminophen Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Isatuximab dexamethasone Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Isatuximab ranitidine Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Isatuximab diphenhydramine Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response Baseline until disease progression or death (maximum duration: 12.1 weeks) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Baseline until death (maximum duration: 12.1 weeks) 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.
Number of Participants With Minimal Residual Disease (MRD) Baseline until death or study cut-off (maximum duration: 12.1 weeks) 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.
Duration of Response (DOR) Baseline until disease progression or death (maximum duration: 12.1 weeks) 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.
Progression Free Survival (PFS) Baseline until disease progression or death (maximum duration: 12.1 weeks) 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.
Trial Locations
- Locations (17)
Investigational Site Number 8400001
🇺🇸Houston, Texas, United States
Investigational Site Number 8400002
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 2460001
🇫🇮Helsinki, Finland
Investigational Site Number 2500001
🇫🇷Paris Cedex 10, France
Investigational Site Number 2500005
🇫🇷Nantes Cedex 01, France
Investigational Site Number 2500004
🇫🇷Pessac, France
Investigational Site Number 3480001
🇭🇺Budapest, Hungary
Investigational Site Number 2500002
🇫🇷Pierre Benite, France
Investigational Site Number 3480003
🇭🇺Budapest, Hungary
Investigational Site Number 3800004
🇮🇹Brescia, Italy
Investigational Site Number 6430003
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number 8400003
🇺🇸Hackensack, New Jersey, United States
Investigational Site Number 3480002
🇭🇺Debrecen, Hungary
Investigational Site Number 4400001
🇱🇹Vilnius, Lithuania
Investigational Site Number 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number 3800001
🇮🇹Bergamo, Italy