Status:
COMPLETED
5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the feasibility and efficacy of using the demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients with high risk myelodyspla...
Detailed Description
The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2 cycles study participants will have a bone marrow test to evaluate the effect of the 5-azacytidine on the Myelodys...
Eligibility Criteria
Inclusion
- Patients fulfilling the following criteria will be eligible for study entry:
- Diagnosis of MDS according to WHO criteria
- Intermediate-2 or high risk by IPSS score
- Clinically able to receive 5-Azacytidine
- Serum bilirubin levels \</=1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) levels \</=2 x ULN
- Serum creatinine levels \</=1.5 x ULN
- Negative serum pregnancy test prior to 5-Azacytidine treatment for women of childbearing potential
- Women and men of childbearing potential agree to use contraception while receiving treatment with 5-Azacytidine
- Potentially eligible for allogeneic transplantation
- No prior allogeneic transplant
- Age 18 to 70, inclusive.
Exclusion
- Known or suspected hypersensitivity to 5-azacytidine or mannitol
- Patients previously treated with 5-azacytidine or deoxyazacytidine
- Pregnant or breast feeding
- Patients with advanced malignant hepatic tumors
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00721214
Start Date
July 1 2008
End Date
June 1 2014
Last Update
March 2 2016
Active Locations (1)
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1
Massey Cancer Center / Virginia Commonwealth University
Richmond, Virginia, United States, 23298