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NCT01624805 · ClinicalTrials.gov registry record · Phase 2
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome
A Phase 2 study of Myelodysplastic Syndrome and Aplastic Anemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT01624805: Recruiting Phase 2 study of Myelodysplastic Syndrome and Aplastic Anemia, sponsored by M.D. Anderson Cancer Center.
NCT01624805 is a Phase 2 study of Myelodysplastic Syndrome and Aplastic Anemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 140 participants, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624805, a Phase 2 study of Myelodysplastic Syndrome and Aplastic Anemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
Primary Outcome
Measured by complete response (CR), partial response, or hematologic improvement.
Conditions Studied
Interventions
- BIOLOGICAL Anti-Thymocyte Globulin
- BIOLOGICAL Filgrastim
- BIOLOGICAL Pegfilgrastim
- DRUG Methylprednisolone
- DRUG Cyclosporine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-06-25 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What NCT01624805 shows while recruiting
NCT01624805 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (32% lower).
The record links to 4 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Anti-Thymocyte Globulin is the first listed.
NCT01624805 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01624805 about?
NCT01624805 is a clinical study titled "Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome". This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse b...
What is the current status of trial NCT01624805?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2012-06-25. Estimated completion is 2026-06-30.
What conditions does trial NCT01624805 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Aplastic Anemia, Previously Treated Myelodysplastic Syndrome, de Novo Myelodysplastic Syndrome.
What interventions are being tested in trial NCT01624805?
The interventions under investigation include: Anti-Thymocyte Globulin (BIOLOGICAL), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), Methylprednisolone (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT01624805?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01624805 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01624805's enrollment target sits among peer trials
140 24th of 134 higher than 110 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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