PRO#0118: Decitabine Plus Mini Flu-Bu
Completed · Phase 1
Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome
In brief
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
Key facts
- Study ID
- NCT01455506
- Run by
- Hackensack Meridian Health
- People needed
- 20
- Starts
- 2009-05-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-02-04
Who can join
Age: 45 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Untreated CNS leukemia
- Active hepatitis or other untreated infections
Where it is running
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States
Full record on ClinicalTrials.gov
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