T-cell Type Acute Leukemia-Precursor Clinical Trial
— ISLAYOfficial title:
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
| Verified date | March 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | November 14, 2017 |
| Est. primary completion date | November 14, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | Inclusion criteria : - Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy. - Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration. - Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue). - No more than 3 prior salvage therapies. Exclusion criteria: - Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration. - Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration. - Clinical evidence of active central nervous system (CNS) leukemia. - T-ALL with testicular involvement alone. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Investigational Site Number 2460001 | Helsinki | |
| France | Investigational Site Number 2500005 | Nantes Cedex 01 | |
| France | Investigational Site Number 2500001 | Paris Cedex 10 | |
| France | Investigational Site Number 2500004 | Pessac | |
| France | Investigational Site Number 2500002 | Pierre Benite | |
| Hungary | Investigational Site Number 3480001 | Budapest | |
| Hungary | Investigational Site Number 3480003 | Budapest | |
| Hungary | Investigational Site Number 3480002 | Debrecen | |
| Italy | Investigational Site Number 3800001 | Bergamo | |
| Italy | Investigational Site Number 3800004 | Brescia | |
| Lithuania | Investigational Site Number 4400001 | Vilnius | |
| Russian Federation | Investigational Site Number 6430001 | Moscow | |
| Russian Federation | Investigational Site Number 6430003 | Moscow | |
| Russian Federation | Investigational Site Number 6430004 | Moscow | |
| United States | Investigational Site Number 8400002 | Atlanta | Georgia |
| United States | Investigational Site Number 8400003 | Hackensack | New Jersey |
| United States | Investigational Site Number 8400001 | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Finland, France, Hungary, Italy, Lithuania, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline until disease progression or death (maximum duration: 12.1 weeks) | |
| Secondary | 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. | Baseline until disease progression or death (maximum duration: 12.1 weeks) | |
| Secondary | 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. | Baseline until disease progression or death (maximum duration: 12.1 weeks) | |
| Secondary | 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. | Baseline until death (maximum duration: 12.1 weeks) | |
| Secondary | 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. | Baseline until death or study cut-off (maximum duration: 12.1 weeks) |