NCT02626338

Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML

Pilot Study of Crenolanib Combined With Standard Salvage Chmetherapy in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.

Detailed description

Open label, dose de-escalation, pilot trial of crenolanib with standard salvage chemotherapy. Subjects may receive up to 2 cycles of induction with standard salvage chemotherapy followed by crenolanib. Each arm will enroll approximately 24 patients (72 total); stratification to each arm will be per physician's choice

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia (AML)

Interventions

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

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2015-12-10
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

4 sites across 1 country: United States