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Clinical Trial 19456

Cancer Type: Malignant Hematology
Interventions:

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Kendra Sweet

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Summary

This study is to compare the efficacy of an investigational drug called crenolanib with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. Crenolanib has not yet been approved for use by the United States Food and Drug Administration (FDA).

Objective

Primary Objective To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival (EFS) in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation. Secondary Objectives To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on: Overall survival, Relapse free survival, Composite complete remission rate, Duration of response To assess the safety and tolerability of crenolanib compared with midostaurin administered following induction chemotherapy and consolidation therapy on: Early death (ED), Duration of hematologic recovery, Incidence and relatedness of adverse events (AE) Explorative objectives 1. To compare the baseline FLT3 allelic burden and treatment outcome of the crenolanib treatment arm with that of midostaurin administered following induction chemotherapy and consolidation therapy 2. To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy by investigating subjects molecular disease response

Inclusion Criteria

> Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification.

  • Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood.
  • Age ≥ 18 years and ≤ 60 years.
  • Adequate hepatic function within 48 hours prior to induction chemotherapy.
  • Adequate renal functions within 48 hours prior to induction chemotherapy.
  • ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3.
  • Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified.

  • Exclusion Criteria

    >Acute promyelocytic leukemia (APL).

  • Known clinically active central nervous system (CNS) leukemia.
  • Severe liver disease.
  • Active infections.
  • Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Known infection with human immunodeficiency virus (HIV).
  • Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis).