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

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Azacitidine; Decitabine; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Patients eligible for allogeneic HCT, independent of age

• Adult patients of any age with a cytopathologically confirmed diagnosis according to WHO classification of newly diagnosed AML (not APL = AML-M3), de novo AML or secondary AML

• in first complete remission (CR1)

• Poor risk or very poor risk subgroups

• WHO performance status ≤ 2

• Written informed consent

Exclusion Criteria:

• Patient not in CR1

• Patients who have senile dementia, mental impairment of any other psychiatric disorder that prohibits the patient from understanding and giving informed consent

• Active serious infections like HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV)

• Patient is unwilling to use contraceptive techniques during and for 12 months following treatment

• Female patient who is pregnant or breastfeeding

• Active and uncontrolled infections