Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Public ClinicalTrials.gov record NCT00075478. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and radiation therapy before a donor 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 cells 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 cyclosporine and mycophenolate mofetil after transplant may stop this from happening. It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer.
Study identification
- NCT ID
- NCT00075478
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 87 participants
Conditions and interventions
Conditions
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Aggressive Non-Hodgkin Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Diffuse Large B-Cell Lymphoma
- Hematopoietic and Lymphoid Cell Neoplasm
- Indolent Non-Hodgkin Lymphoma
- Mantle Cell Lymphoma
- Myelodysplastic/Myeloproliferative Neoplasm
- Plasma Cell Myeloma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hodgkin Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
- Total-Body Irradiation Procedure
- Fludarabine Phosphate Drug
- Mycophenolate Mofetil Drug
- Cyclosporine Drug
- Peripheral Blood Stem Cell Transplantation Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- Up to 75 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
- Sep 30, 2003
- Primary completion
- Jan 31, 2014
- Completion
- Feb 1, 2014
- Last update posted
- May 14, 2017
2003 – 2014
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OHSU Cancer Institute-Southern Region | Medford | Oregon | 97504 | — |
| 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 | — |
| 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 NCT00075478, 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 May 14, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00075478 live on ClinicalTrials.gov.