Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

ClinicalTrials.gov ID: NCT00105001

Public ClinicalTrials.gov record NCT00105001. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.

Study identification

NCT ID: NCT00105001
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Fred Hutchinson Cancer Center; Other
Enrollment: 210 participants

Conditions and interventions

Conditions

Interventions

Fludarabine Phosphate Drug
Total-Body Irradiation Radiation
Peripheral Blood Stem Cell Transplantation Procedure
Allogeneic Hematopoietic Stem Cell Transplantation Procedure
Tacrolimus Drug
Mycophenolate Mofetil Drug
Sirolimus Drug

Drug · Radiation · Procedure

Eligibility (public fields only)

Age range: Not listed
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 31, 2004
Primary completion: Apr 30, 2011
Completion: May 7, 2015
Last update posted: Oct 29, 2019

2004 – 2015

United States locations

U.S. sites: 7
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado	80218	—
Emory University/Winship Cancer Institute	Atlanta	Georgia	30322	—
Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	84112	—
LDS Hospital	Salt Lake City	Utah	84143	—
Veterans Administration Center-Seattle	Seattle	Washington	98108	—
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	98109	—
Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00105001, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 29, 2019 · Synced Sep 12, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00105001 live on ClinicalTrials.gov.

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