NCT03860844 — drugset

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isatuximab	Monoclonal antibody	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Cytarabine	Small molecule	—	Intravenous
Background	Daunorubicin	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	Methotrexate	Small molecule	—	Intravenous
Background	Mitoxantrone	Small molecule	—	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	—	Intravenous
Background	Vincristine	Small molecule	—	Intravenous
Background	asparaginase	Protein / enzyme biologic	—	Intramuscular
Background	filgrastim	Protein / enzyme biologic	—	Intravenous

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

Summary

Timeline

Drugs

Indications