5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

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 myelodysplastic syndrome (MDS).

Key facts

Study ID

NCT00721214

Run by

Virginia Commonwealth University

People needed

16

Starts

2008-07-01

Expected to finish

2014-06-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massey Cancer Center / Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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