Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS
Completed · Phase 2
Conditions studied: Myelodysplastic Syndrome
In brief
Objectives: Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS). Secondary: To evaluate response duration, survival and side effects of the treatment.
Key facts
- Study ID
- NCT00520468
- Run by
- M.D. Anderson Cancer Center
- People needed
- 15
- Starts
- 2004-06-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-08-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with MDS and </= 10% blasts or International Prognostic Scoring System (IPSS) low or intermediate 1. No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2). Prior cytokines, biologic therapies, targeted therapies, or single agent chemotherapy allowed. Procrit, G-CSF are allowed before therapy. Patients with blasts < 5% must have an indication for therapy, such as transfusion needs, symptomatic anemia or Hb < 11g/dl, platelets < 100 x 10 9/L, or granulocytes < 10 9/L.
- Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded)
- Signed informed consent
You may not qualify if…
- Nursing and pregnant females are excluded. Women of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients with active and uncontrolled infections.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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