Last updated on July 2020

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

Brief description of study

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

Detailed Study Description

The study will include a screening period of up to 21 days (Day -21 to -1), a study treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)], a recovery period (until an end of treatment visit [within 30 days after hematological recovery]) and a follow-up period (until final analysis cut off date).

Clinical Study Identifier: NCT03860844

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Recruitment Status: Open

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