Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (ISAKIDS)
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- STATUS
- Recruiting
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- End date
- Aug 31, 2023
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- participants needed
- 96
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- sponsor
- Sanofi
Summary
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
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).
Details
| Condition | Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia |
|---|---|
| Treatment | cyclophosphamide, methotrexate, filgrastim, cytarabine, etoposide, hydroxyurea, Fludarabine, Dexamethasone, Tocilizumab, vincristine, doxorubicin, Mitoxantrone, Idarubicin, Daunorubicin, Montelukast, isatuximab SAR650984, Isatuximab, Liposomal daunorubicin, PEG Asparaginase, L - Asparginase, L - Asparaginase (Erwinase) |
| Clinical Study Identifier | NCT03860844 |
| Sponsor | Sanofi |
| Last Modified on | 7 October 2022 |
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