Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia CRENOLANIB VERSUS MIDOSTAURIN

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Phase 3

Enrollment: 510 patients (estimated)

View More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Illinois

Rush University Medical Center

Chicago, IL

Open and Accepting

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

University of Illinois at Chicago

Chicago, IL

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Iowa

Kansas

University of Kansas Cancer Center (Westwood)

Westwood, KS

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

New Jersey

Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

Commack, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

West Harrison, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message