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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 is a Phase 3 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 101 participants.

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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.

Interventions

  • DRUG Mycophenolate mofetil
  • DRUG tacrolimus
  • DRUG methotrexate
  • DRUG Methotrexate (low dose)

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2014-07-07
Est. Completion 2021-08-11
Phase Phase 3

Sponsor

Case Comprehensive Cancer Center

407 total trials

What the Registry Record Tells You About NCT01951885

The ClinicalTrials.gov registry entry for NCT01951885 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Mycophenolate mofetil is the first listed.

NCT01951885 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.