Clinical trial · Interventional
10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine
- description
- Single arm study: the addition of 10 days (20 mg/m2) decitabine to the conditioning regimen prior to allogeneic hematopoietic transplantation.
- interventionNames
- Drug: decitabine
Primary outcomes (1)
- measure
- Relapse at 1-year after the transplantation procedure
- timeFrame
- At 1-year after the transplantation procedure
- description
- All patients included in this study are in complete morphologic remission. Relapse at 1-year is defined as the % of patients who have relapsed within the first year after transplantation. For the computation of the incidence of relapse at 1-year, death in CR will be considered as a competing risk.
Secondary outcomes (3)
- measure
- Relapse within the first 100 days after the transplantation procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCruijsen M, Hilberink JR, van der Velden WJFM, Jansen JH, Bar B, Schaap NPM, de Haan A, Mulder AB, de Groot MR, Baron F, Vellenga E, Blijlevens NNM, Huls G. Low relapse risk in poor risk AML after conditioning with 10-day decitabine, fludarabine and 2 Gray TBI prior to allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2021 Aug;56(8):1964-1970. doi: 10.1038/s41409-021-01272-3. Epub 2021 Apr 6. PMID 33824442