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Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

NCT03258931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-04-09

No results posted yet for this study

Summary

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Conditions

  • Newly Diagnosed FLT3 Mutated AML

Interventions

DRUG

Crenolanib

Crenolanib will be administered orally

DRUG

Midostaurin

Midostaurin will be administered orally

DRUG

Cytarabine

100 mg/m² IV continuous infusion over 24 hours

DRUG

Duanorubicin

90 mg/m2 IV

Sponsors & Collaborators

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2026-04-06
Completion
2026-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03258931 on ClinicalTrials.gov