NCT03258931

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

Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-08-15
• Primary completion: 2026-04-06
• Completion: 2026-04-06
• First posted: 2017-08-23
• Last updated: 2026-04-09

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study