5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
This trial is active, not recruiting.
|Sponsor||Virginia Commonwealth University|
|Start date||July 2008|
|End date||June 2014|
|Trial size||75 participants|
|Trial identifier||NCT00721214, MCC-11328|
Patients with high risk myelodysplastic syndrome (MDS) responding to 5-azacytidine prior to allogeneic transplant have improved event free and overall survival.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
1 year and 2-year event free and overall survival (EFS and OS) from the time of transplant.
time frame: 3 years
Secondary endpoints will include intent to treat analysis of 1-year and 2-year EFS and OS for all patients receiving 5-Azacytidine from the time of initial therapy as well as engraftment of WBC and platelets, graft failure, relapse and GVHD.
time frame: 3 years
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Patients fulfilling the following criteria will be eligible for study entry: 1. Diagnosis of MDS according to WHO criteria 2. Intermediate-2 or high risk by IPSS score 3. Clinically able to receive 5-Azacytidine 4. 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 5. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) levels =2 x ULN 6. Serum creatinine levels =1.5 x ULN 7. Negative serum pregnancy test prior to 5-Azacytidine treatment for women of childbearing potential 8. Women and men of childbearing potential agree to use contraception while receiving treatment with 5-Azacytidine 9. Potentially eligible for allogeneic transplantation 10. No prior allogeneic transplant 11. Age 18 to 70, inclusive. Exclusion Criteria: 1. Known or suspected hypersensitivity to 5-azacytidine or mannitol 2. Patients previously treated with 5-azacytidine or deoxyazacytidine 3. Pregnant or breast feeding 4. Patients with advanced malignant hepatic tumors
|Official title||A Phase II Study of the Use of 5-Azacytidine as Pre-Transplant Cytoreduction Prior to Allogeneic Stem Cell Transplantation for High Risk Myelodysplastic Syndromes|
|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 Myelodysplastic Syndrome (MDS). Participants continue to get cycles of 5-Azacytidine until 2 bone marrow tests show the MDS has stopped responding to the treatment. At that time they will undergo a transplant if a donor is available.|
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