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NCT01713400 · ClinicalTrials.gov registry record · Phase 2
Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
A Phase 2 study of Graft Vs Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT01713400: Completed Phase 2 study of Graft Vs Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01713400 is a Phase 2 study of Graft Vs Host Disease that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 54 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01713400, a Phase 2 study of Graft Vs Host Disease, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).
Primary Outcome
Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: "T reg" - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulato
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Placebo
- DRUG Ustekinumab
- DRUG Tacrolimus (TAC)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-02-25 |
| Est. Completion | 2018-06-14 |
| Phase | Phase 2 |
What the finished NCT01713400 record still lists
NCT01713400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT01713400 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01713400 about?
NCT01713400 is a clinical study titled "Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease". To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).
What is the current status of trial NCT01713400?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-02-25. Estimated completion is 2018-06-14.
What conditions does trial NCT01713400 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
What interventions are being tested in trial NCT01713400?
The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG), Ustekinumab (DRUG), Tacrolimus (TAC) (DRUG).
Who is sponsoring clinical trial NCT01713400?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01713400 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Graft Vs Host Disease
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 NCT01713400's enrollment target sits among peer trials
54 16th of 36 higher than 21 of 36 other Graft Vs Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft Vs Host Disease 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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