NCT03860844

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

Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 28 Days – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study included: * a screening period of up to (up to 3 weeks prior to the first study treatment administration); * a study treatment period \[Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)\]; * the period of aplasia followed by a recovery period; * an end of treatment (EOT) visit \[within 30 days after hematological recovery; * a follow-up period (until final analysis cut off date).

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Isatuximab	Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous
DRUG	Dexamethasone or equivalent	Pharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral
DRUG	Fludarabine	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Cytarabine	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Liposomal daunorubicin	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Daunorubicin (nonliposomal)	Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
DRUG	Idarubicin	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Filgrastim or equivalent	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Mitoxantrone	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Doxorubicin	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Vincristine	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Pegaspargase (PEG) Asparaginase	Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
DRUG	Cyclophosphamide	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Etoposide	Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
DRUG	Methotrexate	Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
DRUG	L - Asparginase	Pharmaceutical form: Solution for injection Route of administration: Intramuscular
DRUG	Hydroxyurea	Pharmaceutical form: Solution for injection Route of administration: PO
DRUG	L - Asparaginase (Erwinase)	Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Timeline

• Start date: 2019-08-06
• Primary completion: 2022-09-12
• Completion: 2023-05-26
• First posted: 2019-03-04
• Last updated: 2025-09-09
• Results posted: 2023-11-15

Locations

41 sites across 16 countries: United States, Argentina, Brazil, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Norway, Peru, Portugal, South Korea, Sweden

Regulatory

• FDA-regulated drug study