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Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

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

NCT03250338•Arog Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (62)

City of Hope National Medical Center

Sacramento, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

University of Florida

Gainesville, Florida, United States

University of Chicago

Chicago, Illinois, United States

Kansas University

Kansas City, Kansas, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Alberta

Edmonton, Alberta, Canada

Key Dates

Start Date

June 5, 2018

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

April 30, 2021

Enrollment

322

ESTIMATED participants

Conditions

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Interventions

Crenolanib

DRUG

Cytarabine

DRUG

Mitoxantrone

DRUG

Placebo Oral Tablet

DRUG

Fludarabine

DRUG

Idarubicin

DRUG

G-CSF

DRUG

Contacts

General Contact

CONTACT

214-593-0500 info@arogpharma.com