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NCT02133924 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
A Phase 2 study, sponsored by John Levine.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT02133924: Completed Phase 2 study, sponsored by John Levine.
NCT02133924 is a Phase 2 study that has completed, run by John Levine. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02133924, a Phase 2 study, has completed, sponsored by John Levine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.
Primary Outcome
The primary endpoint for this clinical study is the proportion of complete response, CR (that is, the percent of patients with skin, liver, and GI GVHD - all stage 0) at day 28 of study treatment. Stage 0 = no rash, total bilirubin \<2 mg/dl, diarrhea \<500 ml/d
Interventions
- DRUG natalizumab
- DRUG steroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2016-08 |
| Est. Completion | 2021-11-21 |
| Phase | Phase 2 |
What the finished NCT02133924 record still lists
NCT02133924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which natalizumab is the first listed.
NCT02133924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02133924 about?
NCT02133924 is a clinical study titled "Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease". This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone ma...
What is the current status of trial NCT02133924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2016-08. Estimated completion is 2021-11-21.
What interventions are being tested in trial NCT02133924?
The interventions under investigation include: natalizumab (DRUG), steroids (DRUG).
Who is sponsoring clinical trial NCT02133924?
This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02133924's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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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