Acute Lymphocytic Leukaemia Clinical Trial
Official title:
Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: - Response duration - Progression Free Survival - Minimal residual disease - Safety - Pharmacokinetics
The duration of the study for an individual patient will include: - The screening period = up to 4 weeks prior to the first administration of SAR3419. - The treatment period: - Induction period = 4 to 8 weeks - Maintenance = up to a total maintenance treatment of 6 months - A safety follow-up period of 42 days after the last dose. - Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05086315 -
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
|
Phase 1/Phase 2 |