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

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ClinicalTrials.gov Identifier: NCT03250338
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 11, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE June 5, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
Event-free survival (EFS) [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03250338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • Overall Survival [ Time Frame: 3 years ]
  • Relapse-free Survival (RFS) [ Time Frame: 3 years ]
  • Complete remission rate (CR) [ Time Frame: 3 years ]
  • MRD negative complete remission rate [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Official Title  ICMJE Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Intervention  ICMJE
  • Drug: Crenolanib
    Crenolanib will be administered orally
    Other Name: Crenolanib besylate
  • 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
Study Arms  ICMJE
  • Experimental: Crenolanib
    Crenolanib following salvage chemotherapy
    Interventions:
    • Drug: Crenolanib
    • Drug: Cytarabine
    • Drug: Mitoxantrone
    • Drug: Fludarabine
    • Drug: Idarubicin
    • Drug: G-CSF
  • Placebo Comparator: Placebo
    Placebo following salvage chemotherapy
    Interventions:
    • Drug: Cytarabine
    • Drug: Mitoxantrone
    • Drug: Placebo Oral Tablet
    • Drug: Fludarabine
    • Drug: Idarubicin
    • Drug: G-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2017)
322
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mamta Puri-Lechner, PhD 2145930548 mpurilechner@arogpharma.com
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03250338
Other Study ID Numbers  ICMJE ARO-013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arog Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arog Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eunice Wang, MD Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
PRS Account Arog Pharmaceuticals, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP