Phase 2
N=14
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS
Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00520468 ↗Enrolled (actual)
14
Serious AEs
78.6%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Response — 2; 2; 4; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erythropoietin (Drug); Cyclosporin A (Drug); G-CSF (Drug); Prednisone (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response |
2; 2; 4; 6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with MDS and /= 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00520468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.