Clinical trial · Interventional
PRO#0118: Decitabine Plus Mini Flu-Bu
PRO#0118: A Phase I Study of Decitabin in Combination With Fludarabin and Busulfan as a Reduced Intensity Conditioning Regimen for the Treatment of Myeloid Malignancies
- 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 is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will receive treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to allogeneic stem cell transplantation. Subjects will be followed until 1 year post transplantation to assess stability of engraftment, toxicity, progression free survival, and disease response
Conditions
Conditions (2)
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine plus Fludarabine and Busulfan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine with fludarabine and busulfan
- description
- decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation
- interventionNames
- Drug: Decitabine plus Fludarabine and Busulfan
Primary outcomes (1)
- measure
- To assess the effect of decitabine in combination with fludarabine and busulfan prior to allogeneic stem cell transplantation on the rate of primary graft rejection
- timeFrame
- up to 1 year post transplantation
- description
- Graft failure defined by the presence of \<10% donor lymphoid cells on peripheral blood analysis performed on post transplant day 84(+/- 10 days) in patients who have not relapsed will be measured.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute myelogenous leukemia or myelodysplastic syndrome being considered for transplantation. * Age 45 to 80 years or \< 45 with co-morbidity including: disease not in remission * No uncontrolled infections. * Patients shall have a 6/6 HLA-compatible related donor or an 8/8 -HLA-compatible unrelated donor. * KPS 70-100% * Creatinine \< 1.6 X ULN (unless age \< 45 yrs) * Serum Bilirubin \< 2.5 X ULN * Capable of giving informed consent and have signed the informed consent form. * Cardiac EF \> 50% or cardiac clearance * Pulmonary DLCO \> 50% or pulmonary clearance Exclusion Criteria: * Untreated CNS leukemia * Active hepatitis or other untreated infections
References
Publications (0)
Data not yet available