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NCT00105001 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 11
- Study locations
NCT00105001 is a Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 210 participants, below the 467-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 6 states.
The verdict
NCT00105001, a Phase 2 study of Waldenstrom Macroglobulinemia and Refractory Plasma Cell Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 11
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2004-11 |
| Est. Completion | 2015-05-08 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 467-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (55% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
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.
NCT00105001 reports 11 study locations spanning 6 distinct geographic areas - top geographies include Other, Utah, Washington.
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.
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).
Who is sponsoring clinical trial NCT00105001?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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.
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