A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies

Trial Profile

A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Oct 2017

At a glance

  • Drugs Isatuximab (Primary) ; Dexamethasone
  • Indications Acute lymphoblastic leukaemia; Acute myeloid leukaemia; B cell lymphoma; Chronic lymphocytic leukaemia; Multiple myeloma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 29 Jun 2016 ISAdex arm added to the treatment table which contains Isatuximab + Dexamethasone in phase 2 portion of the study. Study design changed from single group assignment to parallel assignment along with change in planned patient number.
    • 23 Jun 2016 Planned number of patients changed from 278 to 341.
    • 07 Jun 2016 Phase II results (n=97) presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
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