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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 : Completed
First Posted : March 27, 2015
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Study Description
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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
Acute Myeloid Leukemia Drug: Crenolanib besylate Drug: Idarubicin Drug: Cytarabine Drug: Azacytidine Drug: Mitoxantrone Drug: Etoposide Drug: Fludarabine Drug: G-CSF 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
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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: CP-868,596-26

Drug: Idarubicin
Other Name: 4-demethoxydaunorubicin

Drug: Cytarabine
Other Name: cytosine arabinoside

Drug: Mitoxantrone
Other Name: Novantrone

Drug: Etoposide
Other Name: etoposide phosphate

Drug: Fludarabine
Other Name: Fludarabine phosphate

Drug: G-CSF
Experimental: Arm 2 crenolanib besylate combination
Arm 2 patients will receive crenolanib besylate and azacytidine.
 Drug: Crenolanib besylate
Other Name: CP-868,596-26

Drug: Azacytidine
Other Name: 5-azacytidine


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicities of crenolanib besylate combination therapy [ Time Frame: 6 months ]
  2. Response rate of crenolanib besylate combination therapy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: 2 years ]
  2. Progression free survival [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400281


Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Jorge Cortes, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02400281    
Other Study ID Numbers: ARO-010
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine
Fludarabine phosphate
Etoposide
Etoposide phosphate
Azacitidine
Mitoxantrone
Idarubicin
Crenolanib
Antineoplastic Agents
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents