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

Description

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.

Study Start Date

January 2015

Estimated Completion Date

July 2017

Interventions

  • Drug: idarubicin
  • Drug: crenolanib
  • Drug: daunorubicin
  • Drug: cytarabine

Specialties

  • Internal Medicine: Hematology/Oncology
  • Oncology: Leukemia/Lymphoma
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Leukemia
  • Myeloid
  • cytarabine
  • daunorubicin

Study ID

Arog Pharmaceuticals LLC -- ARO-006

Status

Unknown

Trial ID

NCT02283177

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

48

Sponsor

Arog Pharmaceuticals LLC

Inclusion Criteria

    1. Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia 2. Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents. No prior therapy for AML in this setting is allowed 3. Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations within 3 weeks before or within 5 days after start of induction chemotherapy. 4. Age ?18 years 5. ECOG PS 0
  • 2 6. No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis 7. Adequate liver function, defined as bilirubin normal, ALT ?2.0x ULN, and AST ?2.0x ULN
  • adequate renal function, defined as serum creatinine ?1.5x ULN or GFR >50 mL/min 8. Non-pregnant and non-nursing 9. Able and willing to provide written informed consent

Exclusion Criteria

    1. Active CNS leukemia 2. 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 3. NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy 4. Unable to swallow pills 5. Major surgical procedures within 14 days of administration of crenolanib central line placement is not considered major surgery: 6. Unwillingness or inability to comply with protocol. 7. Concurrent use of other investigational agents for the duration of participation on this study 8. Subjects who are not eligible for standard chemotherapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Richard Stone MD None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Martin Tallman MD None None
Roswell Park Cancer Institute - Buffalo, New York 397.2 miles Eunice Wang MD None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Hetty Carraway MD None None
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Robert Collins MD None robert.collins@utsouthwestern.edu
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,487.7 miles Roland Walter MD PhD None None

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