drugset / Trial / NCT02252107

10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1

NCT02252107 ↗

Phase 2 Completed 46 enrolled Radboud University Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This study examines whether the addition of decitabine to the standard Flu/TBI conditioning regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any side effects, it will likely have little impact on the occurrence of Graft Versus Host Disease. The investigators are looking for a pre-treatment for transplantation which reduces the chance of recurrence of the disease without involving severe damage to normal tissues.

Timeline

Start
2014-10
Primary completion
2019-05
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 —