Overview

Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

Status:
Completed

Trial end date:
2018-07-13

Target enrollment:

Participant gender:

Summary

This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy. Sample size: 144 patients Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial) Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)

Phase:

Phase 3

Details

Lead Sponsor:

University of Ulm

Collaborator:

German Federal Ministry of Education and Research

Treatments:

Cytarabine
Etoposide
Etoposide phosphate
Tretinoin