Houston, Texas 77030


Purpose:

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


Study summary:

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.


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)


NCT ID:

NCT02400281


Primary Contact:

Abhijit Ramachandran
Phone: 214-593-0515
Email: aramachandran@arogpharma.com


Backup Contact:

Email: vurity@arogpharma.com
Vinoo Urity
Phone: 214-593-0521


Location Contact:

Houston, Texas 77030
United States

Jorge Cortes, MD
Email: jcortes@mdanderson.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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