Status:
COMPLETED
10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1
Lead Sponsor:
Radboud University Medical Center
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Acute myeloid leukemia (AML) is a heterogeneous group of malignant hematological diseases with different molecular genetic abnormalities. These are important in predicting response to treatment. Recen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02252107
Start Date
October 1 2014
End Date
May 1 2019
Last Update
March 19 2020
Active Locations (3)
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1
University of Liège
Liège, Belgium
2
University Medical Center Groningen (UMCG)
Groningen, Netherlands
3
Radboud university medical center
Nijmegen, Netherlands, 6500 HB