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

Arog Pharmaceuticals, Inc.62 sites in 6 countries322 target enrollmentJune 5, 2018

ConditionsRelapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

InterventionsCrenolanib Cytarabine Mitoxantrone Fludarabine Idarubicin G-CSF Placebo Oral Tablet

DrugsCrenolanib Cytarabine Mitoxantrone Placebo Oral Tablet Fludarabine Idarubicin G-CSF

Overview

Phase: Phase 3
Intervention: Crenolanib
Conditions: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Sponsor: Arog Pharmaceuticals, Inc.
Enrollment: 322
Locations: 62
Primary Endpoint: Event-free survival (EFS)
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 5, 2018

End Date

October 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Arog Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
•Presence of FLT3-ITD and/or D835 mutation(s)
•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
•Age ≥ 18 years and ≤ 75 years
•Adequate hepatic function
•Adequate renal functions
•ECOG performance status ≤ 3

Exclusion Criteria

•Known clinically active central nervous system(CNS) leukemia
•Severe liver disease
•Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
•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.
•Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.