- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001839
A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
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Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
MDS of RA & RAEB sub-types.
No current treatment and off other treatments for at least two weeks.
ECOG performance status less than or equal to 2.
No MDS of FAB sub-group' refractory anemia with ring sideroblasts' (RARS).
No transforming to acute leukemia (FAB sub-group RAEB-Tie.; greater than 20% blasts in marrow aspirate).
No hypoplastic marrow without one major or two minor criteria as outlined in table 3 of the appendix.
No one being treatment with growth factors or cyclosporine within four weeks prior to entry to protocol.
No previous treatment with ATG.
No ECOG performance status of greater than 2.
No active uncontrolled infection.
No women which current pregnancy, or unwilling to take oral contraceptives if of childbearing potential.
No patients for whom bone marrow transplant is indicated as primary therapy.
No one age less than 18 years.
Must be able to give informed consent.
No HIV positive patients.
No active malignant disease (excluding basal cell carcinoma).
No one with serum creatine greater than 2mg/dl.
No patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 7-10 days is likely.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease
- Bone Marrow Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Preleukemia
- Hematologic Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Antilymphocyte Serum
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 990021
- 99-CC-0021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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