Acute Myeloid Leukemia Clinical Trial

A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

Summary

This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
No prior therapy for AML, except for hydroxyurea, in this setting is allowed.
Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents
Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations
Age ≥18 years
ECOG PS 0 - 2
Adequate liver function, defined as normal total bilirubin, ALT ≤2.0x ULN, and AST ≤2.0x ULN measured within 24 hours prior to crenolanib commencement
Adequate renal function, defined as serum creatinine ≤1.5x ULN or GFR >50 mL/min

Negative pregnancy test (serum or urine) for women of childbearing potential (WOCBP)

• Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months or with bilateral tubal ligation

WOCBP must practice contraception. Acceptable methods of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligations, and abstention
Male patients (except those with prior surgical contraceptive procedures) with female partners who are of childbearing potential: Recommendation is for male and partner to use effective contraceptive methods, such as latex condoms, during the study
Able and willing to provide written informed consent

Exclusion Criteria:

Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.)
Active CNS leukemia
Subject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy
Unable to swallow pills
Major surgical procedures within 14 days of administration of crenolanib (does not include line placement as needed for chemotherapy administration).
Unwillingness or inability to comply with protocol.
Concurrent use of other investigational agents.
Subjects who are not eligible for standard chemotherapy

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT02283177

Recruitment Status:

Completed

Sponsor:

Arog Pharmaceuticals, Inc.

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There are 8 Locations for this study

See Locations Near You

City of Hope Medical Center
Duarte California, 91010, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT02283177

Recruitment Status:

Completed

Sponsor:


Arog Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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