Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)

Stopped early · Phase 2

Conditions studied: Leukemia

In brief

The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied. Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.

Key facts

Study ID

NCT01542684

Run by

M.D. Anderson Cancer Center

People needed

8

Starts

2012-03-01

Expected to finish

2013-04-01

Last updated by the study team

2014-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with low- or intermediate-1-risk MDS according to the International Prognostic Scoring System (IPSS) classification
• Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UT MD Anderson Cancer Center.
• Age >/= 18 years old.
• Prior therapy with growth factor support, lenalidomide, or other investigational agents is allowed.
• Previously untreated patients are eligible for this study.

You may not qualify if…

• Any previous adverse reaction (>/= Common Terminology Criteria for Adverse Events (CTCAE) grade 2) to GM-CSF.
• Prior treatment with azacytidine or decitabine.
• Unresolved diarrhea >/= CTCAE grade 2.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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