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

Primary Purpose

Newly Diagnosed FLT3 Mutated AML

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Crenolanib
Midostaurin
Cytarabine
Duanorubicin
Sponsored by
Arog Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed FLT3 Mutated AML

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • Ronald Reagan UCLA Medical CenterRecruiting
  • US Davis HealthRecruiting
  • Yale Cancer CenterRecruiting
  • Moffitt Cancer CenterRecruiting
  • Rush Medical CenterRecruiting
  • University of Illinois at ChicagoRecruiting
  • University of ChicagoRecruiting
  • Indiana UniversityRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of KansasRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deacnss Medical Center OncologyRecruiting
  • Dana-Farber Cancer InsituteRecruiting
  • Karmanos Cancer InstituteRecruiting
  • Henry Ford Health SystemRecruiting
  • University of MinnesotaRecruiting
  • John Theurer Cancer Center at Hackensack UMCRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Montefiore Medical CenterRecruiting
  • Roswell PArkRecruiting
  • New York UniversityRecruiting
  • Mount SinaiRecruiting
  • Columbia UniversityRecruiting
  • Cornell UniversityRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • University of Rochester Medical CenterRecruiting
  • The UNC Lineberger Comprehensive Cancer CenterRecruiting
  • Wake Forest Baptist Health, Section on Hematology & OncologyRecruiting
  • Oregon Health and Science UniversityRecruiting
  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crenolanib

Midostaurin

Arm Description

Crenolanib following salvage chemotherapy

Midostaurin following salvage chemotherapy

Outcomes

Primary Outcome Measures

Event-free survival (EFS)

Secondary Outcome Measures

Overall Survival
Relapse free survival
Composite complete remission rate
Duration of response

Full Information

First Posted
August 21, 2017
Last Updated
May 21, 2020
Sponsor
Arog Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03258931
Brief Title
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arog Pharmaceuticals, Inc.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed FLT3 Mutated AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crenolanib
Arm Type
Experimental
Arm Description
Crenolanib following salvage chemotherapy
Arm Title
Midostaurin
Arm Type
Active Comparator
Arm Description
Midostaurin following salvage chemotherapy
Intervention Type
Drug
Intervention Name(s)
Crenolanib
Other Intervention Name(s)
Crenolanib besylate
Intervention Description
Crenolanib will be administered orally
Intervention Type
Drug
Intervention Name(s)
Midostaurin
Intervention Description
Midostaurin will be administered orally
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
100 mg/m² IV continuous infusion over 24 hours
Intervention Type
Drug
Intervention Name(s)
Duanorubicin
Intervention Description
90 mg/m2 IV
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
7 years
Title
Relapse free survival
Time Frame
5 years
Title
Composite complete remission rate
Time Frame
5 years
Title
Duration of response
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
General Contact
Phone
214-593-0500
Email
info@arogpharma.com
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chatchada Karanes, MD
Phone
626-218-2405
Email
CKaranes@coh.org
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caspian Oliai, MD
Phone
310-206-5756
Email
COliai@mednet.ucla.edu
Facility Name
US Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Jonas, MD
Phone
800-282-3284
Email
bajonas@ucdavis.edu
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolai Podoltsev, MD
Phone
203-737-7059
Email
nikolai.podoltsev@yale.edu
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Sweet, MD
Phone
813-745-6841
Email
Kendra.Sweet@moffitt.org
Facility Name
Rush Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Larson, MD
Phone
312-942-5978
Email
melissa_larson@rush.edu
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Quigley, MD
Phone
312-413-1300
Email
seanq@uic.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Liu, MD
Phone
773-834-0589
Email
hliu2@medicine.bsd.uchicago.edu
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206-5149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heiko Konig, MD
Phone
317-274-3590
Email
hkonig@iupui.edu
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Vigil-Gonzales, MD
Phone
319-356-1206
Email
carlos-vigil@uiowa.edu
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Abhyankar, MD
Phone
913-588-9281
Email
sabhyankar@kumc.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Fathi, MD
Phone
617-724-1124
Email
AFATHI@mgh.harvard.edu
Facility Name
Beth Israel Deacnss Medical Center Oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata McMasters, MD
Phone
617-667-9920
Email
mmcmaste@bidmc.harvard.edu
Facility Name
Dana-Farber Cancer Insitute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard M Stone, MD
Phone
617-632-2214
Email
Richard_Stone@dfci.harvard.edu
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Yang, MD
Phone
800-527-6266
Email
yangj@karmanos.org
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Guo, MD
Phone
800-436-7936
Email
YGUO1@hfhs.org
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Warlick, MD
Phone
612-625-5467
Email
ewarlick@umn.edu
Facility Name
John Theurer Cancer Center at Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Koprivnikar, MD
Phone
551-996-5900
Email
Jamie.Koprivnikar@hackensackmeridian.org
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Kritharis, MD
Phone
732-235-4439
Email
athena.kritharis@rutgers.edu
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditi Shastri, MD
Phone
718-920-4826
Email
ASHASTRI@montefiore.org
Facility Name
Roswell PArk
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunice S Wang, MD
Phone
716-845-3544
Email
eunice.wang@roswellpark.org
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Abdul Hay, MD
Phone
646-501-4818
Email
Maher.Abdulhay@nyulangone.org
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mascarenhas, MD
Phone
212-241-3417
Email
John.mascarenhas@mssm.edu
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Jurcic, MD
Phone
646-317-5077
Email
jgj2110@cumc.columbia.edu
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinkal Desai, MD
Phone
646-962-2700
Email
pid9006@med.cornell.edu
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Goldberg, MD
Phone
212-639-2126
Email
goldbera@mskcc.org
Facility Name
University of Rochester Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Liesveld, MD
Phone
585-275-5295
Email
jane_liesveld@urmc.rochester.edu
Facility Name
The UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Zeidner, MD
Phone
919-966-4432
Email
Joshua_Zeidner@med.unc.edu
Facility Name
Wake Forest Baptist Health, Section on Hematology & Oncology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupali Roy Bhave, MD
Phone
336-713-0864
Email
rbhave@wakehealth.edu
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie Traer, MD
Phone
503-418-9614
Email
traere@ohsu.edu
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Keng, MD
Phone
319-356-1206
Email
MK2PV@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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