Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant

Completed · Not applicable

Conditions studied: Leukemia

In brief

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) is helpful in preventing their myelodysplastic syndrome from coming back. In previous research, 5-Azacitidine appeared to help the bone marrow of a patient with MDS begin to function more normally. This means bone marrow cells can grow and do their work the way they were meant to. 5-Azacitidine is approved by the Food and Drug Administration (FDA) for the treatment of MDS. The effect of 5-Azacitidine in patients receiving hematopoietic cell transplants have not been studied.

Key facts

Study ID

NCT00660400

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

25

Starts

2008-03-01

Expected to finish

2014-06-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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