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NCT01104025 · ClinicalTrials.gov registry record · Phase 2
Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01104025: Completed Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01104025 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104025, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH) remains difficult to treat. Two different treatment regimens have been used successfully. The first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has been used worldwide. The second regimen, based on two drugs called Anti-thymocyte globulin (ATG) and prednisone, has been used mostly at one hospital in Paris, for over 15 years. With either regimen, about three quarters of treated children survive the most difficult time, the first two months after diagnosis. These two different regimens appear to work somewhat differently, and we suspect that combining them may give better results than either regimen alone. We are conducting this clinical trial to test the combination of ATG, dexamethasone, and etoposide for the treatment of HLH. The purpose of this research study is to find out what effects (good and bad) this drug combination has on you and your HLH.
Primary Outcome
To determine the overall survival of patients with hemophagocytic lymphohistiocytosis at 8 weeks after an ATG/etoposide-based induction regimen and to determine the feasibility of this approach in the context of a multicenter clinical trial.
Interventions
- DRUG Etoposide
- DRUG Dexamethasone
- DRUG Methotrexate
- DRUG hydrocortisone
- DRUG ATG, rabbit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01104025 record still lists
NCT01104025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Etoposide is the first listed.
NCT01104025 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104025 about?
NCT01104025 is a clinical study titled "Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis". Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH) remains difficult to treat. Two different treatment regimens have been used successfully. The first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has been used worldwide. The seco...
What is the current status of trial NCT01104025?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01104025?
The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Methotrexate (DRUG), hydrocortisone (DRUG), ATG, rabbit (DRUG).
Who is sponsoring clinical trial NCT01104025?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01104025's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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