Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01790568
The ClinicalTrials.gov registry entry for NCT01790568 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (81% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
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.
-
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
RECRUITING · Phase 2
-
A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
RECRUITING · Phase 2
-
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
RECRUITING · Phase 2
-
Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD
ACTIVE NOT RECRUITING · Phase 2
-
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure
ACTIVE NOT RECRUITING · Phase 2
-
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
COMPLETED · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.