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

About the trial

Sponsor

Sanofi

Tested

Isatuximab (drug), Dexamethasone or equivalent (drug), Fludarabine (drug), Cytarabine (drug), Liposomal daunorubicin (drug), Daunorubicin (nonliposomal) (drug), Idarubicin (drug), Filgrastim or equivalent (drug), Mitoxantrone (drug), Doxorubicin (drug), Vincristine (drug), Pegaspargase (PEG) Asparaginase (drug), Cyclophosphamide (drug), Etoposide (drug), Methotrexate (drug), L - Asparginase (drug), Hydroxyurea (drug), L - Asparaginase (Erwinase) (drug)

Dates

Started 2019-08-06; completion 2023-05-26

Results posted

Yes

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

From ClinicalTrials.gov, last updated 2025-09-09. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $1,983 in research payments for this study in 2025 (1 payments).

Products named: Sarclisa

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.