Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2023-08-31

Summary

Primary Objective:

To 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

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Etoposide; Fludarabine; Hydroxyurea; Idarubicin; Methotrexate; Mitoxantrone; Montelukast; Pegaspargase; Vincristine