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

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ClinicalTrials.gov Identifier: NCT03258931
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Newly Diagnosed FLT3 Mutated AML Drug: Crenolanib Drug: Midostaurin Drug: Cytarabine Drug: Duanorubicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024


Arm Intervention/treatment
Experimental: Crenolanib
Crenolanib following salvage chemotherapy
Drug: Crenolanib
Crenolanib will be administered orally
Other Name: 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




Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 7 years ]
  2. Relapse free survival [ Time Frame: 5 years ]
  3. Composite complete remission rate [ Time Frame: 5 years ]
  4. Duration of response [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03258931


Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Yuliya Linhares, MD    310-423-1160    Yuliya.Linhares@cshs.org   
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Chatchada Karanes, MD    626-218-2405    CKaranes@coh.org   
US Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Brian Jonas, MD    800-282-3284    bajonas@ucdavis.edu   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Kendra Sweet, MD    813-745-6841    Kendra.Sweet@moffitt.org   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hongtao Liu, MD       hliu2@medicine.bsd.uchicago.edu   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46206-5149
Contact: Heiko Konig, MD       hkonig@iupui.edu   
United States, Kansas
University of Kansas Medical Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Sunil Abhyankar, MD       sabhyankar@kumc.edu   
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sunil Abhyankar, MD    913-588-9281    sabhyankar@kumc.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amir Fathi, MD       AFATHI@mgh.harvard.edu   
Dana-Farber Cancer Insitute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Richard M Stone, MD    617-632-2214    Richard_Stone@dfci.harvard.edu   
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jay Yang, MD    800-527-6266    yangj@karmanos.org   
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Yue Guo, MD    800-436-7936    YGUO1@hfhs.org   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Erica Warlick, MD       ewarlick@umn.edu   
United States, New York
Roswell PArk Recruiting
Buffalo, New York, United States, 14263
Contact: Eunice S Wang, MD    716-845-3544    eunice.wang@roswellpark.org   
Mount Sinai Recruiting
New York, New York, United States, 10029-6574
Contact: John Mascarenhas, MD    212-241-3417    John.mascarenhas@mssm.edu   
Cornell University Recruiting
New York, New York, United States, 10065
Contact: Pinkal Desai, MD    646-962-2700    pid9006@med.cornell.edu   
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Aaron Goldberg, MD    212-639-2126    goldbera@mskcc.org   
University of Rochester Medical Center Recruiting
New York, New York, United States, 14642
Contact: Jane Liesveld, MD       jane_liesveld@urmc.rochester.edu   
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.

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Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03258931     History of Changes
Other Study ID Numbers: ARO-021
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cytarabine
Midostaurin
Crenolanib
Staurosporine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors