Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Purpose

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Condition

  • Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification 2. Presence of FLT3-ITD and/or D835 mutation(s) 3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML 4. Age ≥ 18 years and ≤ 75 years 5. Adequate hepatic function 6. Adequate renal functions 7. ECOG performance status ≤ 3

Exclusion Criteria

  1. Known clinically active central nervous system(CNS) leukemia 2. Severe liver disease 3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Crenolanib 		Crenolanib following salvage chemotherapy
  • Drug: Crenolanib
    Crenolanib will be administered orally
    Other names:
    • Crenolanib besylate
  • Drug: Cytarabine
    HAM regimen FLAG-Ida
  • Drug: Mitoxantrone
    HAM regimen
  • Drug: Fludarabine
    FLAG-Ida regimen
  • Drug: Idarubicin
    FLAG-Ida regimen
  • Drug: G-CSF
    FLAG-Ida regimen
Placebo Comparator
Placebo 		Placebo following salvage chemotherapy
  • Drug: Cytarabine
    HAM regimen FLAG-Ida
  • Drug: Mitoxantrone
    HAM regimen
  • Drug: Placebo Oral Tablet
    Placebo will be administered orally
  • Drug: Fludarabine
    FLAG-Ida regimen
  • Drug: Idarubicin
    FLAG-Ida regimen
  • Drug: G-CSF
    FLAG-Ida regimen

Recruiting Locations

More Details

NCT ID
NCT03250338
Status
Completed
Sponsor
Arog Pharmaceuticals, Inc.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center