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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

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
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 5344147, California 5332921 91010
Contact:
Chatchada Karanes, MD
626-218-2405
CKaranes@coh.org

Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095
Contact:
Caspian Oliai, MD
310-206-5756
COliai@mednet.ucla.edu

US Davis Health
Sacramento 5389489, California 5332921 95817
Contact:
Brian Jonas, MD
800-282-3284
bajonas@ucdavis.edu

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510
Contact:
Nikolai Podoltsev, MD
203-737-7059
nikolai.podoltsev@yale.edu

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
Kendra Sweet, MD
813-745-6841
Kendra.Sweet@moffitt.org

Rush Medical Center
Chicago 4887398, Illinois 4896861 60612
Contact:
Melissa Larson, MD
312-942-5978
melissa_larson@rush.edu

University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612
Contact:
John G Quigley, MD
312-413-1300
seanq@uic.edu

University of Chicago
Chicago 4887398, Illinois 4896861 60637
Contact:
Hongtao Liu, MD
773-834-0589
hliu2@medicine.bsd.uchicago.edu

Indiana University
Indianapolis 4259418, Indiana 4921868 46206-5149
Contact:
Heiko Konig, MD
317-274-3590
hkonig@iupui.edu

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
Contact:
Carlos Vigil-Gonzales, MD
319-356-1206
carlos-vigil@uiowa.edu

University of Kansas
Kansas City 4273837, Kansas 4273857 66160
Contact:
Sunil Abhyankar, MD
913-588-9281
sabhyankar@kumc.edu

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Amir Fathi, MD
617-724-1124
AFATHI@mgh.harvard.edu

Beth Israel Deacnss Medical Center Oncology
Boston 4930956, Massachusetts 6254926 02215
Contact:
Malgorzata McMasters, MD
617-667-9920
mmcmaste@bidmc.harvard.edu

Dana-Farber Cancer Insitute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Richard M Stone, MD
617-632-2214
Richard_Stone@dfci.harvard.edu

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Contact:
Jay Yang, MD
800-527-6266
yangj@karmanos.org

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
Contact:
Yue Guo, MD
800-436-7936
YGUO1@hfhs.org

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Erica Warlick, MD
612-625-5467
ewarlick@umn.edu

John Theurer Cancer Center at Hackensack UMC
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Jamie Koprivnikar, MD
551-996-5900
Jamie.Koprivnikar@hackensackmeridian.org

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Athena Kritharis, MD
732-235-4439
athena.kritharis@rutgers.edu

Roswell PArk
Buffalo 5110629, New York 5128638 14263
Contact:
Eunice S Wang, MD
716-845-3544
eunice.wang@roswellpark.org

New York University
New York 5128581, New York 5128638 10016
Contact:
Mohammad Abdul Hay, MD
646-501-4818
Maher.Abdulhay@nyulangone.org

Mount Sinai
New York 5128581, New York 5128638 10029-6574
Contact:
John Mascarenhas, MD
212-241-3417
John.mascarenhas@mssm.edu

Columbia University
New York 5128581, New York 5128638 10032
Contact:
Joseph Jurcic, MD
646-317-5077
jgj2110@cumc.columbia.edu

Cornell University
New York 5128581, New York 5128638 10065
Contact:
Pinkal Desai, MD
646-962-2700
pid9006@med.cornell.edu

Memorial Sloan-Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Aaron Goldberg, MD
212-639-2126
goldbera@mskcc.org

University of Rochester Medical Center
New York 5128581, New York 5128638 14642
Contact:
Jane Liesveld, MD
585-275-5295
jane_liesveld@urmc.rochester.edu

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
Contact:
Aditi Shastri, MD
718-920-4826
ASHASTRI@montefiore.org

The UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
Joshua Zeidner, MD
919-966-4432
Joshua_Zeidner@med.unc.edu

Wake Forest Baptist Health, Section on Hematology & Oncology
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Rupali Roy Bhave, MD
336-713-0864
rbhave@wakehealth.edu

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Elie Traer, MD
503-418-9614
traere@ohsu.edu

University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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