Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Purpose

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Condition

  • Newly Diagnosed FLT3 Mutated AML

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification - Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood - Age ≥ 18 years and ≤ 60 years - Adequate hepatic function within 48 hours prior to induction chemotherapy - Adequate renal functions within 48 hours prior to induction chemotherapy - ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3 - Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified

Exclusion Criteria

  • Acute promyelocytic leukemia (APL) - Known clinically active central nervous system (CNS) leukemia - Severe liver disease - Active infections - Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) - Known infection with human immunodeficiency virus (HIV) - Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Crenolanib 		Crenolanib following salvage chemotherapy
  • Drug: Crenolanib
    Crenolanib will be administered orally
    Other names:
    • Crenolanib besylate
  • Drug: Cytarabine
    100 mg/m² IV continuous infusion over 24 hours
  • Drug: Duanorubicin
    90 mg/m2 IV
Active Comparator
Midostaurin 		Midostaurin following salvage chemotherapy
  • Drug: Midostaurin
    Midostaurin will be administered orally
  • Drug: Cytarabine
    100 mg/m² IV continuous infusion over 24 hours
  • Drug: Duanorubicin
    90 mg/m2 IV

Recruiting Locations

City of Hope National Medical Center
Duarte, California 91010
Contact:
Chatchada Karanes, MD
626-218-2405
CKaranes@coh.org

Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
Contact:
Caspian Oliai, MD
310-206-5756
COliai@mednet.ucla.edu

US Davis Health
Sacramento, California 95817
Contact:
Brian Jonas, MD
800-282-3284
bajonas@ucdavis.edu

Yale Cancer Center
New Haven, Connecticut 06510
Contact:
Nikolai Podoltsev, MD
203-737-7059
nikolai.podoltsev@yale.edu

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Kendra Sweet, MD
813-745-6841
Kendra.Sweet@moffitt.org

Rush Medical Center
Chicago, Illinois 60612
Contact:
Melissa Larson, MD
312-942-5978
melissa_larson@rush.edu

University of Illinois at Chicago
Chicago, Illinois 60612
Contact:
John G Quigley, MD
312-413-1300
seanq@uic.edu

University of Chicago
Chicago, Illinois 60637
Contact:
Hongtao Liu, MD
773-834-0589
hliu2@medicine.bsd.uchicago.edu

Indiana University
Indianapolis, Indiana 46206-5149
Contact:
Heiko Konig, MD
317-274-3590
hkonig@iupui.edu

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
Contact:
Carlos Vigil-Gonzales, MD
319-356-1206
carlos-vigil@uiowa.edu

University of Kansas
Kansas City, Kansas 66160
Contact:
Sunil Abhyankar, MD
913-588-9281
sabhyankar@kumc.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Amir Fathi, MD
617-724-1124
AFATHI@mgh.harvard.edu

Beth Israel Deacnss Medical Center Oncology
Boston, Massachusetts 02215
Contact:
Malgorzata McMasters, MD
617-667-9920
mmcmaste@bidmc.harvard.edu

Dana-Farber Cancer Insitute
Boston, Massachusetts 02215
Contact:
Richard M Stone, MD
617-632-2214
Richard_Stone@dfci.harvard.edu

Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Jay Yang, MD
800-527-6266
yangj@karmanos.org

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Yue Guo, MD
800-436-7936
YGUO1@hfhs.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Erica Warlick, MD
612-625-5467
ewarlick@umn.edu

John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey 07601
Contact:
Jamie Koprivnikar, MD
551-996-5900
Jamie.Koprivnikar@hackensackmeridian.org

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
Contact:
Athena Kritharis, MD
732-235-4439
athena.kritharis@rutgers.edu

Montefiore Medical Center
Bronx, New York 10467
Contact:
Aditi Shastri, MD
718-920-4826
ASHASTRI@montefiore.org

Roswell PArk
Buffalo, New York 14263
Contact:
Eunice S Wang, MD
716-845-3544
eunice.wang@roswellpark.org

New York University
New York, New York 10016
Contact:
Mohammad Abdul Hay, MD
646-501-4818
Maher.Abdulhay@nyulangone.org

Mount Sinai
New York, New York 10029-6574
Contact:
John Mascarenhas, MD
212-241-3417
John.mascarenhas@mssm.edu

Columbia University
New York, New York 10032
Contact:
Joseph Jurcic, MD
646-317-5077
jgj2110@cumc.columbia.edu

Cornell University
New York, New York 10065
Contact:
Pinkal Desai, MD
646-962-2700
pid9006@med.cornell.edu

Memorial Sloan-Kettering Cancer Center
New York, New York 10065
Contact:
Aaron Goldberg, MD
212-639-2126
goldbera@mskcc.org

University of Rochester Medical Center
New York, New York 14642
Contact:
Jane Liesveld, MD
585-275-5295
jane_liesveld@urmc.rochester.edu

The UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27514
Contact:
Joshua Zeidner, MD
919-966-4432
Joshua_Zeidner@med.unc.edu

Wake Forest Baptist Health, Section on Hematology & Oncology
Winston-Salem, North Carolina 27157
Contact:
Rupali Roy Bhave, MD
336-713-0864
rbhave@wakehealth.edu

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Elie Traer, MD
503-418-9614
traere@ohsu.edu

University of Virginia Health System
Charlottesville, Virginia 22908
Contact:
Michael Keng, MD
319-356-1206
MK2PV@hscmail.mcc.virginia.edu

More Details

NCT ID
NCT03258931
Status
Unknown status
Sponsor
Arog Pharmaceuticals, Inc.

Study Contact

General Contact
214-593-0500
info@arogpharma.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center