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NCT00806598 · ClinicalTrials.gov registry record · Phase 2
Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT00806598: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00806598 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806598, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy will also be studied.
Primary Outcome
Complete response (CR) was defined as normalization of peripheral blood and bone marrow with \<5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9/l, hemoglobin \>/= 100g/l, and a platelet count \>/= \* 10\^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC \>=/ 0.05 \* 10\^9/l, a platelet count \>/= 20 \* 10\^9/l, and a hemoglobin \>/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, plat
Interventions
- DRUG G-CSF
- DRUG Thymoglobulin
- DRUG Methylprednisolone
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2005-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT00806598 record still lists
NCT00806598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which G-CSF is the first listed.
NCT00806598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806598 about?
NCT00806598 is a clinical study titled "Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome". The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy wil...
What is the current status of trial NCT00806598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2005-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00806598?
The interventions under investigation include: G-CSF (DRUG), Thymoglobulin (DRUG), Methylprednisolone (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00806598?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00806598's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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