Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Summary
Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: * Safety and tolerability assessments * Assessment of infusion reactions (IRs) * Pharmacokinetics (PK) of isatuximab * Minimal residual disease * Overall response rate * Overall survival * Event free survival * Duration of response * Relationship between clinical effects and CD38 receptor density and occupancy
Timeline
- Start
- 2019-08-06
- Primary completion
- 2022-09-12
- Completion
- 2023-05-26
Outcome
Outcome not reported
Stopped (Business): “Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Daunorubicin (nonliposomal) | Unknown | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Hydroxyurea | Other / unclassified | — | Oral |
| Background | Idarubicin | Small molecule | — | Intravenous |
| Background | L - Asparginase | Unknown | — | Intramuscular |
| Background | L-asparaginase | Protein / enzyme biologic | — | Intramuscular |
| Background | Liposomal daunorubicin | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | — | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Intravenous |