Expired Study
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Richmond, Virginia 23298


Purpose:

Patients with high risk myelodysplastic syndrome (MDS) responding to 5-azacytidine prior to allogeneic transplant have improved event free and overall survival.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00721214


Primary Contact:

Study Chair
John M. McCarty, MD
Virginia Commonwealth University


Backup Contact:

N/A


Location Contact:

Richmond, Virginia 23298
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 15, 2018

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