Trials Today

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

Purpose

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.

Condition

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Crenolanib	Crenolanib following salvage chemotherapy	Drug: Crenolanib Crenolanib will be administered orally Other names: Crenolanib besylate Drug: Cytarabine HAM regimen FLAG-Ida Drug: Mitoxantrone HAM regimen Drug: Fludarabine FLAG-Ida regimen Drug: Idarubicin FLAG-Ida regimen Drug: G-CSF FLAG-Ida regimen
Placebo Comparator Placebo	Placebo following salvage chemotherapy	Drug: Cytarabine HAM regimen FLAG-Ida Drug: Mitoxantrone HAM regimen Drug: Placebo Oral Tablet Placebo will be administered orally Drug: Fludarabine FLAG-Ida regimen Drug: Idarubicin FLAG-Ida regimen Drug: G-CSF FLAG-Ida regimen

Recruiting Locations

City of Hope National Medical Center
Sacramento 5389489, California 5332921 95817

Contact:
Chatchada Karanes, MD
626-218-2405
CKaranes@coh.org

UC Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817

Contact:
Brian Jonas, MD
916-734-5959

University of Florida
Gainesville 4156404, Florida 4155751 32610

Contact:
Jack Hsu, MD
352-273-7832
jack.hsu@medicine.ufl.edu

University of Chicago
Chicago 4887398, Illinois 4896861 60637

Contact:
Hongtao Liu, MD
hliu@medicine.bsd.uchicago.edu

Kansas University
Kansas City 4273837, Kansas 4273857 666160

Contact:
Sunil Abhyankar, MD

Karmanos Cancer Center
Detroit 4990729, Michigan 5001836 48201

Contact:
Jay Yang, MD
yangj@karmanos.org

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Contact:
Yue Guo, MD

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263

Contact:
Eunice Wang, MD

Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27104

Contact:
Rupali Bhave, MD
336-716-5487
rbhave@wakehealth.edu

More Details

NCT ID: NCT03250338
Status: Unknown status
Sponsor: Arog Pharmaceuticals, Inc.

Study Contact

General Contact
214-593-0500
info@arogpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.