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

Sponsor
Arog Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02400281
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
58.4
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Crenolanib besylate
Other Names:
  • CP-868,596-26

    • Drug: Idarubicin
    Other Names:
  • 4-demethoxydaunorubicin

    • Drug: Cytarabine
    Other Names:
  • cytosine arabinoside

    • Drug: Mitoxantrone
    Other Names:
  • Novantrone

    • Drug: Etoposide
    Other Names:
  • etoposide phosphate

    • Drug: Fludarabine
    Other Names:
  • Fludarabine phosphate

    • Drug: G-CSF
    Experimental: Arm 2 crenolanib besylate combination

    Arm 2 patients will receive crenolanib besylate and azacytidine.

    Drug: Crenolanib besylate
    Other Names:
  • CP-868,596-26

    • Drug: Azacytidine
    Other Names:
  • 5-azacytidine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicities of crenolanib besylate combination therapy [6 months]

    2. Response rate of crenolanib besylate combination therapy [2 years]

    Secondary Outcome Measures

    1. Duration of response [2 years]

    2. Progression free survival [2 years]

    3. Overall survival [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. FLT3 mutation positive (ITD, TKD or other)

    2. ECOG PS 0-2

    3. Adequate liver and renal function

    4. Negative pregnancy test

    5. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Arog Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Jorge Cortes, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arog Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02400281
    Other Study ID Numbers:
    • ARO-010
    First Posted:
    Mar 27, 2015
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Cytarabine
    Fludarabine
    Fludarabine phosphate
    Etoposide
    Etoposide phosphate
    Azacitidine
    Mitoxantrone
    Idarubicin
    Crenolanib

    Study Results

    No Results Posted as of Jul 20, 2020