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NCT01951885 · ClinicalTrials.gov registry record · Phase 3
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
A Phase 3 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT01951885: Completed Phase 3 study, sponsored by Case Comprehensive Cancer Center.
NCT01951885 is a Phase 3 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01951885, a Phase 3 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.
Primary Outcome
Participants (percentage of) will be graded three times per week through day 28 of the study. Incidence will be compared through Wilcoxon rank sum tests. The WHO grading scale for mucositis is scaled depending on the severity of mucositis symptoms, with a lower stage associated with a better outcome and greater stages associated with worse outcomes. The staging is as follows: Stage 0: None Stage 1 (mild): Oral soreness, erythema Stage 2 (moderate): Oral erythema, ulcers, solid diet tolerated S
Interventions
- DRUG Mycophenolate mofetil
- DRUG tacrolimus
- DRUG methotrexate
- DRUG Methotrexate (low dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2014-07-07 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 3 |
What the finished NCT01951885 record still lists
NCT01951885 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate mofetil is the first listed.
NCT01951885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01951885 about?
NCT01951885 is a clinical study titled "Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention". This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil an...
What is the current status of trial NCT01951885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2014-07-07. Estimated completion is 2021-08-11.
What interventions are being tested in trial NCT01951885?
The interventions under investigation include: Mycophenolate mofetil (DRUG), tacrolimus (DRUG), methotrexate (DRUG), Methotrexate (low dose) (DRUG).
Who is sponsoring clinical trial NCT01951885?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01951885's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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