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Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

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Trial Profile

Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 02 Sep 2024

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At a glance

  • Drugs Isatuximab (Primary) ; Asparaginase; Crisantaspase; Cyclophosphamide; Cytarabine; Daunorubicin; Daunorubicin liposomal; Dexamethasone; Dexamethasone; Doxorubicin; Etoposide; Filgrastim; Filgrastim; Fludarabine; Idarubicin; Methotrexate; Mitoxantrone; Montelukast; Pegaspargase; Tocilizumab; Vincristine
  • Indications Acute myeloid leukaemia; Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor T-cell lymphoblastic leukaemia-lymphoma
  • Focus Therapeutic Use
  • Acronyms ISAKIDS
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

Most Recent Events

  • 01 Sep 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
  • 01 Feb 2024 According to a Sanofi media release, trial has fulfilled its pediatric investigation plan (PIP) as part of the overall clinical development plan.
  • 01 Oct 2023 This trial has been completed in France (26 May 2023).

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