Status:
COMPLETED
PRO#0118: Decitabine Plus Mini Flu-Bu
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
FEMALE
45-80 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Aberrant DNA methylation patterns are commonly found in malignant cells. Hypermethylation of gene promotes sequences in cancer cells resulting in transcriptional silencing of tumor suppressor genes an...
Eligibility Criteria
Inclusion
- 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
- Untreated CNS leukemia
- Active hepatitis or other untreated infections
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01455506
Start Date
May 1 2009
End Date
December 1 2013
Last Update
February 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601