Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 75
Updated:3/8/2019
Start Date:June 5, 2018
End Date:October 2021
Contact:Arun Prashar, MD
Email:aprashar@arogpharma.com
Phone:2144514523

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Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

This is a randomized, multi-center, double-blind, placebo-controlled study designed to
evaluate the efficacy of crenolanib administered following salvage chemotherapy,
consolidation chemotherapy, post bone marrow transplantation and as maintenance in
relapsed/refractory AML subjects with FLT3 activating mutation.


Inclusion Criteria:

1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016
classification

2. Presence of FLT3-ITD and/or D835 mutation(s)

3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for
AML or refractory or relapsed after second line of treatment for AML

4. Age ≥ 18 years and ≤ 75 years

5. Adequate hepatic function

6. Adequate renal functions

7. ECOG performance status ≤ 3

Exclusion Criteria:

1. Known clinically active central nervous system(CNS) leukemia

2. Severe liver disease

3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of
quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior
use of hydroxyurea or other palliative treatment for leukocytosis is allowed.

5. Previous treatment with crenolanib or prior participation in clinical trial involving
crenolanib.
We found this trial at
10
sites
Detroit, Michigan 48202
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Eunice Wang, MD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Detroit, Michigan 48202
Principal Investigator: Yue Guo, MD
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Detroit, MI
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Kansas City, Kansas 66616
Principal Investigator: Sunil Abhyankar, MD
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Kansas City, KS
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Meldola,
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4501 X St
Sacramento, California 95817
(916) 734-5800
Phone: 916-734-5959
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sacramento, CA
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Sacramento, California 95817
Phone: 626-218-2405
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Sacramento, CA
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Winston-Salem, North Carolina 27157
Phone: 336-716-5487
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Winston-Salem, NC
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