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NCT00001839 · ClinicalTrials.gov registry record · Phase 2
A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
A Phase 2 study of Myelodysplastic Syndromes and Hematologic Diseases, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
- 1
- Study location
NCT00001839: Completed Phase 2 study of Myelodysplastic Syndromes and Hematologic Diseases, sponsored by National Institutes of Health Clinical Center (CC).
NCT00001839 is a Phase 2 study of Myelodysplastic Syndromes and Hematologic Diseases that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 182 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001839, a Phase 2 study of Myelodysplastic Syndromes and Hematologic Diseases, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II pilot study of anti-thymocyte globin (ATG) to treat myelodysplastic syndrome (MDS); 41% of patients (61% of patients with refractory anemia) have responded in terms of transfusion independence. Recently, Jonasova et al \[32\] reported a 82% substantial hematological response rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine alone. Just over 50% of the patients in this series had MDS of the hypocellular type. Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS. This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS (which constitute approximately 70% of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized comparison with the other immunomodulating intervention of proven benefit, ATG, is appropriate. In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone.
Conditions Studied
Interventions
- DRUG Cyclosporine
- DRUG Antithymocyte globulin
Study Locations (1)
Maryland
- Warren G. Magnuson Clinical Center (CC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 1998-12 |
| Est. Completion | 2000-05 |
| Phase | Phase 2 |
What the finished NCT00001839 record still lists
NCT00001839 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (36% lower).
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Cyclosporine is the first listed.
NCT00001839 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001839 about?
NCT00001839 is a clinical study titled "A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome". Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II pilot study of anti-...
What is the current status of trial NCT00001839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 1998-12. Estimated completion is 2000-05.
What conditions does trial NCT00001839 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Hematologic Diseases.
What interventions are being tested in trial NCT00001839?
The interventions under investigation include: Cyclosporine (DRUG), Antithymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT00001839?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001839 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001839's enrollment target sits among peer trials
182 36th of 173 higher than 138 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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