NCT02400281

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine

Detailed description

For each arm: The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design. Phase II total of 52 patients (26 per arm) will be treated at established phase I dose. Enrollment to be simultaneous to each arm.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Crenolanib besylate
DRUG	Idarubicin
DRUG	Cytarabine
DRUG	Azacytidine
DRUG	Mitoxantrone
DRUG	Etoposide
DRUG	Fludarabine
DRUG	G-CSF

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2015-03-27
• Last updated: 2024-07-03
• Results posted: 2024-03-20

Locations

1 site across 1 country: United States