Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

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:

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


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.