A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

NCT02283177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-02

Study results available
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Summary

This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.

Conditions

  • Newly Diagnosed AML With FLT3 Activating Mutations

Interventions

DRUG

crenolanib

DRUG

cytarabine

DRUG

daunorubicin

DRUG

idarubicin

Sponsors & Collaborators

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Stone, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283177 on ClinicalTrials.gov