Status:
COMPLETED
Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
The purpose of this study is to find out if treating people who have high-risk myelodysplastic syndrome (MDS) with 5-Azacitidine (Vidaza) prior to their allogeneic hematopoietic cell transplant (HCT) ...
Detailed Description
RESEARCH PLAN * This will be a single-center prospective trial * Patients with high risk MDS that are potentially eligible for HCT will be enrolled. * A donor search will be initiated, and 5-Azacitid...
Eligibility Criteria
Inclusion
- Potential candidate for HCT.
- Histologically confirmed diagnosis by pathologic review of previous diagnosis of high-risk myelodysplastic syndrome (MDS): International Prognostic Scoring System (IPSS) \> 1 or AML-MDS or treatment related MDS.
- Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis; Serum glutamic-oxaloacetic transaminase (SGOT) \[aspartate aminotransferase (AST)\] or serum glutamic pyruvic transaminase (SGPT) \[alanine aminotransferase (ALT)\] levels ≤2 x ULN.
- Serum creatinine levels ≤1.5 x ULN
- Karnofsky performance status greater or equal to 70%
- Signed informed consent form in accordance with institutional policies
Exclusion
- Known or suspected hypersensitivity to Vidaza or mannitol
- Pregnant or lactating women
- Human immunodeficiency virus (HIV) or seropositive, confirmed by nucleic acid amplification testing (NAT)
- Active central nervous system (CNS) malignancy
- Active infection
- History or presence of primary hepatoma
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00660400
Start Date
March 1 2008
End Date
June 1 2014
Last Update
September 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612