Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400281
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date January 7, 2020
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • Dose-limiting toxicities of crenolanib besylate combination therapy [ Time Frame: 6 months ]
  • Response rate of crenolanib besylate combination therapy [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • Duration of response [ Time Frame: 2 years ]
  • Progression free survival [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 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 of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Official Title  ICMJE Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Brief Summary This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine
Detailed Description

For each arm:

The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design.

Phase II total of 52 patients (26 per arm) will be treated at established phase I dose.

Enrollment to be simultaneous to each arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Crenolanib besylate
    Other Name: CP-868,596-26
  • Drug: Idarubicin
    Other Name: 4-demethoxydaunorubicin
  • Drug: Cytarabine
    Other Name: cytosine arabinoside
  • Drug: Azacytidine
    Other Name: 5-azacytidine
  • Drug: Mitoxantrone
    Other Name: Novantrone
  • Drug: Etoposide
    Other Name: etoposide phosphate
  • Drug: Fludarabine
    Other Name: Fludarabine phosphate
  • Drug: G-CSF
Study Arms  ICMJE
  • Experimental: Arm 1 crenolanib besylate combination
    Arm 1 patients will receive crenolanib besylate, combined with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin
    Interventions:
    • Drug: Crenolanib besylate
    • Drug: Idarubicin
    • Drug: Cytarabine
    • Drug: Mitoxantrone
    • Drug: Etoposide
    • Drug: Fludarabine
    • Drug: G-CSF
  • Experimental: Arm 2 crenolanib besylate combination
    Arm 2 patients will receive crenolanib besylate and azacytidine.
    Interventions:
    • Drug: Crenolanib besylate
    • Drug: Azacytidine
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed diagnosis of refractory/relapsed AML or high-risk MDS

    • Arm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapies
    • Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
  2. FLT3 mutation positive (ITD, TKD or other)
  3. ECOG PS 0-2
  4. Adequate liver and renal function
  5. Negative pregnancy test
  6. Extramedullary leukemia allowed except CNS disease

Exclusion Criteria:

  • Arm 1 and 2 Exclusion:

    1. <5% blasts in marrow or blood at time of screening
    2. Active HIV, hepatitis B or C
    3. CNS leukemia
    4. Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
    5. Patient with AML-M3 (APL)
    6. Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400281
Other Study ID Numbers  ICMJE ARO-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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: Jorge Cortes, MD M.D. Anderson Cancer Center
PRS Account Arog Pharmaceuticals, Inc.
Verification Date January 2020

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