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NCT01790568 · ClinicalTrials.gov registry record · Phase 2
Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant
A Phase 2 study of Graft Vs Host Disease and Hematologic Neoplasms, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01790568: Completed Phase 2 study of Graft Vs Host Disease and Hematologic Neoplasms, sponsored by University of Michigan Rogel Cancer Center.
NCT01790568 is a Phase 2 study of Graft Vs Host Disease and Hematologic Neoplasms that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 26 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790568, a Phase 2 study of Graft Vs Host Disease and Hematologic Neoplasms, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After completing enrollment of the planned 12 subjects, we are extending the study to an additional 25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat, the study drug, to standard medications to try to prevent or lower the risk of graft versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or marrow stem cell transplants. The transplant regimens, chosen according to current institutional policy, will depend upon the recipients underlying disease (their blood cancer or other blood disorder), previous therapy, and current health issues. GVHD prophylaxis (preventive drug intervention) will be the local institutional standard for post-transplant immunosuppression, including tacrolimus and methotrexate, plus vorinostat. Vorinostat will be given twice daily orally beginning 10 days prior to the recipient's transplant and continue for up to 100 days after transplant.
Primary Outcome
GVHD Staging: Grade 2: (Skin) Maculopapular rash 25-50% BSA, (Liver) bilirubin 3.1-6mg/dl, (Gut) 1000-1500 ml/day for adult and 20-30ml/kg/day for child. Grade 3: (Skin) Maculopapular rash \>50% BSA, (Liver) 6.1-15mg/dl, (Gut) \>1500mg/day for adult and \>30ml/kg/day for child. Grade 4: (Skin) Generalized erythroderma plus bullous formation and desquamation \>5% BSA, (Liver) \>15mg/dl, (Gut) Severe abdominal pain with or without ileus, or grossly bloody stool.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Vorinostat
- DRUG Methotrexate
Study Locations (1)
Michigan
- University of Michigan Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-10-31 |
| Phase | Phase 2 |
What the finished NCT01790568 record still lists
NCT01790568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Graft Vs Host Disease appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus is the first listed.
NCT01790568 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01790568 about?
NCT01790568 is a clinical study titled "Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant". This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After completing enrollment of the planned 12 subjects, we are extending the study to an additional 25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat, the study drug, to standa...
What is the current status of trial NCT01790568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2014-12. Estimated completion is 2017-10-31.
What conditions does trial NCT01790568 study?
This clinical trial studies the following conditions: Graft Vs Host Disease, Hematologic Neoplasms, Non-Neoplastic Hematologic and Lymphocytic Disorder.
What interventions are being tested in trial NCT01790568?
The interventions under investigation include: Tacrolimus (DRUG), Vorinostat (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01790568?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01790568 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01790568's enrollment target sits among peer trials
26 32nd of 36 higher than 4 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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