Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer

ClinicalTrials.gov ID: NCT00089011

Public ClinicalTrials.gov record NCT00089011. 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 Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil

Brief summary

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

This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

Study identification

NCT ID: NCT00089011
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Fred Hutchinson Cancer Center; Other
Enrollment: 150 participants

Conditions and interventions

Conditions

Interventions

fludarabine phosphate Drug
total-body irradiation Radiation
mycophenolate mofetil Drug
tacrolimus Drug
peripheral blood stem cell transplantation Procedure
nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure
laboratory biomarker analysis Other

Drug · Radiation · Procedure + 1 more

Eligibility (public fields only)

Age range: Up to 74 Years
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: Mar 31, 2004
Primary completion: Feb 28, 2014
Completion: Jun 30, 2018
Last update posted: Jan 28, 2020

2004 – 2018

United States locations

U.S. sites: 4
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	84112	—
LDS Hospital	Salt Lake City	Utah	84143	—
VA Puget Sound Health Care System	Seattle	Washington	98101	—
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	98109	—

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 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00089011, 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 Jan 28, 2020 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00089011 live on ClinicalTrials.gov.

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