Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
NCT03860844 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2025-09-09
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
Conditions
Interventions
- 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
-
Pharmaceutical form: Solution for injection Route of administration: Intravenous
- DRUG
-
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
-
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 28 Days
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-06
- Primary Completion
- 2022-09-12
- Completion
- 2023-05-26
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Denmark
- France
- Germany
- Greece
- Hungary
- Italy
- Mexico
- Netherlands
- Norway
- Peru
- Portugal
- South Korea
- Sweden
Study Locations
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