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Sponsor: Sanofi
Conditions: T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
Interventions: Isatuximab SAR650984, dexamethasone, dexamethasone, acetaminophen, ranitidine
Countries: United States, Finland, France, Hungary, Italy, Lithuania, Russia
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.
Sex: ALL
Age: 16 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
- Houston, Texas, United States
- Helsinki, Finland
- Nantes, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Budapest, Hungary
- Budapest, Hungary
- Debrecen, Hungary
- Bergamo, Italy
- Brescia, Italy
- Vilnius, Lithuania
- Moscow, Russia
- Moscow, Russia
- Moscow, Russia