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NCT03116477 Clinical Trial

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

Acute Myeloid Leukemia, in Relapse Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03116477
Other study ID # ARO-013
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received April 12, 2017
Last updated April 17, 2017
Start date August 2017
Est. completion date August 2020

Study information
Verified date April 2017
Source Arog Pharmaceuticals, Inc.
Contact VArtika Agarwal
Email vagarwal@davacro.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, randomized, trial to evaluate the efficacy of adding crenolanib to salvage chemotherapy versus salvage chemotherapy alone in subjects with relapsed/refractory FLT3-mutant AML. Approximately 320 subjects will be randomized 1:1 to receive either salvage chemotherapy (HAM or FLAG-Ida) with crenolanib (treatment arm 1) or salvage chemotherapy (HAM or FLAG-Ida) alone (treatment arm 2).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 320
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Crenolanib besylate

• Cytarabine

• Mitoxantrone

• Fludarabine

• Idarubicin

• G-CSF

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Arog Pharmaceuticals, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) 2 years
Secondary Complete Response with or without count recovery (CR/CRi) based on modified ELN 2017 criteria 2 years
Secondary Event-free survival (EFS) 2 years
Secondary Relapse-free survival (RFS) 2 years
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