Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
NCT ID: NCT02400281
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2015-09-30
2020-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Crenolanib besylate
Idarubicin
Cytarabine
Mitoxantrone
Etoposide
Fludarabine
G-CSF
Arm 2 crenolanib besylate combination
Arm 2 patients will receive crenolanib besylate and azacytidine.
Crenolanib besylate
Azacytidine
Interventions
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Crenolanib besylate
Idarubicin
Cytarabine
Azacytidine
Mitoxantrone
Etoposide
Fludarabine
G-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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)
18 Years
ALL
No
Sponsors
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Arog Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jorge Cortes, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ARO-010
Identifier Type: -
Identifier Source: org_study_id
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