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Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS

NCT00520468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-08-07

Study results available
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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.

Conditions

Interventions

DRUG

Erythropoietin

40,000 units injected under the skin (SQ) weekly

DRUG

Cyclosporin A

300 mg (tablets) by mouth daily for 6 months

DRUG

G-CSF

300 mcg injected under the skin (SQ) two times per week

DRUG

Prednisone

60 mg per day for 7 days, taper over 1 month

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur, MBBS · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520468 on ClinicalTrials.gov