Clinical trial · Interventional
SAR3419 in Acute Lymphoblastic Leukemia
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
NCT01440179CI-TRIAL-00060948MYRALLterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is stopped due to very modest activity compared to competitors
Summary
Brief summary (as posted)
Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: * Response duration * Progression Free Survival * Minimal residual disease * Safety * Pharmacokinetics
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukaemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR3419 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAR3419
- description
- Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.
- interventionNames
- Drug: SAR3419
Primary outcomes (1)
- measure
- Number of participants achieving an Objective Response Rate
- timeFrame
- 4 to 8 weeks
Secondary outcomes (7)
- measure
- Number of participants with Adverse Events
- timeFrame
- Up to 1 year
- measure
- Assessment of PK parameter - maximum concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion criteria: * Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration. * No more than 3 prior salvage therapies. * Philadelphia positive patients failing treatment with imatinib mesylate are accepted. * CD19 positive patients. Exclusion criteria: None The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDCarol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20. PMID 23426279