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NCT01251575 · ClinicalTrials.gov registry record · Phase 2

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
77
Enrollment target

NCT01251575 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 77 participants.

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The verdict

NCT01251575, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
77 participants
Enrollment target

Study Summary

This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Mycophenolate Mofetil
  • DRUG Fludarabine Phosphate
  • DRUG Cyclosporine
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2010-12-01
Est. Completion 2019-02-11
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT01251575

The ClinicalTrials.gov registry entry for NCT01251575 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01251575 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01251575 about?

NCT01251575 is a clinical study titled "Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant". This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor periphera...

What is the current status of trial NCT01251575?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2010-12-01. Estimated completion is 2019-02-11.

What interventions are being tested in trial NCT01251575?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Cyclosporine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01251575?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 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.