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NCT01246206 · ClinicalTrials.gov registry record · Phase 2
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01246206: Completed Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01246206 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01246206, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant. Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years. Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.
Primary Outcome
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
Interventions
- DRUG Tacrolimus and Thymoglobulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01246206 record still lists
NCT01246206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus and Thymoglobulin is the first listed.
NCT01246206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01246206 about?
NCT01246206 is a clinical study titled "Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT". The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and...
What is the current status of trial NCT01246206?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2010-11. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01246206?
The interventions under investigation include: Tacrolimus and Thymoglobulin (DRUG).
Who is sponsoring clinical trial NCT01246206?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01246206's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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