NCT02942758

Low-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML

Randomized Phase II Trial With Safety run-in Phase Evaluating Low-dose AZA, ATRA and Pioglitazone Versus Standard Dose Azacitidine in Patients >=60 Years With AML Who Are Refractory to Standard Induction Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital Regensburg · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60 years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety Run-In Phase; randomized Phase II, open-label * Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for the randomized phase II is defined. * Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm: standard-dose azacitidine; in both arms patients can receive further cycles (with no limit to the number given) as long as clinically appropriate

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	low-dose Azacitidine	Azacitidine 75 mg/d s.c. for 7 days, repeated 28-day treatment cycle
DRUG	Pioglitazone	Pioglitazone 45 mg p.o. continuously from day 1
DRUG	ATRA	ATRA \*45 mg/m² p.o. from day 1 to 28, 15 mg/m² from day 29 continuously; \*this regimen will be chosen for the first dose to be evaluated.
DRUG	standard-dose AZA	Azacitidine 75 mg/m²/d s.c. for 7 days, repeated 28-day treatment cycle

Timeline

• Start date: 2017-04-10
• Primary completion: 2020-03-25
• Completion: 2020-03-25
• First posted: 2016-10-24
• Last updated: 2024-05-08

Locations

1 site across 1 country: Germany