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COMPLETED Phase 2

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

NCT00105001 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • RADIATION Total-Body Irradiation
  • DRUG Fludarabine Phosphate
  • DRUG Tacrolimus
  • PROCEDURE Peripheral Blood Stem Cell Transplantation
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (11)

Other

  • Rigshospitalet University Hospital — Copenhagen
  • Medizinische Univ Klinik Koln — Cologne
  • Universitaet Leipzig — Leipzig
  • University of Tuebingen-Germany — Tübingen

Utah

  • Huntsman Cancer Institute/University of Utah — Salt Lake City
  • LDS Hospital — Salt Lake City

Washington

  • Veterans Administration Center-Seattle — Seattle
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle

Colorado

  • Presbyterian - Saint Lukes Medical Center - Health One — Denver

Georgia

  • Emory University/Winship Cancer Institute — Atlanta

Wisconsin

  • Froedtert and the Medical College of Wisconsin — Milwaukee

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2004-11
Est. Completion 2015-05-08
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

319 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00105001

The ClinicalTrials.gov registry entry for NCT00105001 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 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 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 5 interventions — of which Total-Body Irradiation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00105001 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Other, Utah, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00105001 about?

NCT00105001 is a clinical study titled "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". 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 f...

What is the current status of trial NCT00105001?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2004-11. Estimated completion is 2015-05-08.

What conditions does trial NCT00105001 study?

This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Refractory Plasma Cell Myeloma, Refractory Chronic Lymphocytic Leukemia, Adult Acute Myeloid Leukemia in Remission, Previously Treated Myelodysplastic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00105001?

The interventions under investigation include: Total-Body Irradiation (RADIATION), Fludarabine Phosphate (DRUG), Tacrolimus (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00105001?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00105001 being conducted?

This trial has 11 study locations across Colorado, Georgia, Utah, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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