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

  • STATUS
    Not Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    96
  • sponsor
    Sanofi
Updated on 25 November 2022
remission
fludarabine
cyclophosphamide
lymphoma
hydroxyurea
myelodysplasia
methotrexate
cytarabine
filgrastim
minimal residual disease
daunorubicin
residual tumor
mitoxantrone
idarubicin

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, Liposomal daunorubicin, PEG Asparaginase, L - Asparginase, L - Asparaginase (Erwinase)
Clinical Study IdentifierNCT03860844
SponsorSanofi
Last Modified on25 November 2022

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