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

This study is currently recruiting participants.
Verified October 2016 by Arog Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02283177
First Posted: November 5, 2014
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Newly Diagnosed AML With FLT3 Activating Mutations Drug: crenolanib Drug: cytarabine Drug: daunorubicin Drug: idarubicin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Tolerability Trial of Crenolanib and Chemotherapy With Cytarabine and Anthracyclines in Patients With Newly Diagnosed Acute Myeloid Leukemia With FLT3 Activating Mutations

Resource links provided by NLM:


Further study details as provided by Arog Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • The safety and tolerability of crenolanib in combination with chemotherapy will be determined by assessing the adverse events experienced by patients. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Patients' serum and plasma samples will be collected and pharmacokinetic parameters including Cmax and AUC will be measured. [ Time Frame: day 4 and day 15 of induction 1; day 7 of consolidation 1 ]
  • Response rate [ Time Frame: day 14-28 of induction ]

Estimated Enrollment: 48
Study Start Date: January 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Patients will be given cytarabine and daunorubicin during induction therapy plus crenolanib at 100 mg TID.
Drug: crenolanib
Other Name: CP-868,596-26
Drug: cytarabine Drug: daunorubicin
Experimental: Cohort B
Patients will be given cytarabine and idarubicin during induction therapy plus crenolanib at 100 mg TID.
Drug: crenolanib
Other Name: CP-868,596-26
Drug: cytarabine Drug: idarubicin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
  2. No prior therapy for AML, except for hydroxyurea, in this setting is allowed.
  3. Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents
  4. Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations
  5. Age ≥18 years
  6. ECOG PS 0 - 2
  7. 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
  8. Adequate renal function, defined as serum creatinine ≤1.5x ULN or GFR >50 mL/min
  9. 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

  10. 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
  11. 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
  12. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.)
  2. Active CNS leukemia
  3. 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
  4. NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy
  5. Unable to swallow pills
  6. Major surgical procedures within 14 days of administration of crenolanib (does not include line placement as needed for chemotherapy administration).
  7. Unwillingness or inability to comply with protocol.
  8. Concurrent use of other investigational agents.
  9. Subjects who are not eligible for standard chemotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283177


Contacts
Contact: Abhijit Ramachandran 214-593-0515 aramachandran@arogpharma.com
Contact: Vinoo Urity 214-593-0521 vurity@arogpharma.com

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Chatchada Karanes, MD       ckaranes@coh.org   
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Carlos Vigil, MD       carlos-vigil@uiowa.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Richard Stone, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Eunice Wang, M.D.         
Principal Investigator: Eunice Wang, M.D.         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Martin Tallman, MD.         
Contact: Martin Tallman, MD         
Principal Investigator: Faye Feller, M.D.         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Gail Roboz, MD       gar2001@med.cornell.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hetty Carraway, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Robert Collins, MD       robert.collins@utsouthwestern.edu   
Principal Investigator: Robert Collins, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98195
Contact: Roland Walter, MD, PhD         
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
  More Information

Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02283177     History of Changes
Other Study ID Numbers: ARO-006
First Submitted: October 29, 2014
First Posted: November 5, 2014
Last Update Posted: October 12, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Crenolanib
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors