MedTrace Logo

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

NCT02942758 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Anticancer Fund, Belgium

    collaborator OTHER

  • Celgene

    collaborator INDUSTRY

  • University Hospital Regensburg

    lead OTHER

Principal Investigators

  • Simone Thomas, Dr. · University Hospital Regensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02942758 on ClinicalTrials.gov