Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
Public ClinicalTrials.gov record NCT01231412. 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 Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor Hematopoietic Cell 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 III trial studies how well graft-vs-host disease (GVHD) prophylaxis works in treating patients with hematologic malignancies undergoing unrelated donor peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU), cyclosporine (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop this from happening.
Study identification
- NCT ID
- NCT01231412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 174 participants
Conditions and interventions
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Aggressive Non-Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Diffuse Large B-Cell Lymphoma
- Hematopoietic and Lymphoid Cell Neoplasm
- Indolent Non-Hodgkin Lymphoma
- Mantle Cell Lymphoma
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Prolymphocytic Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Plasma Cell Myeloma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Refractory Hodgkin Lymphoma
- Small Lymphocytic Lymphoma
- T-Cell Chronic Lymphocytic Leukemia
- Waldenstrom Macroglobulinemia
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Cyclosporine Drug
- Fludarabine Phosphate Drug
- Mycophenolate Mofetil Drug
- Peripheral Blood Stem Cell Transplantation Procedure
- Sirolimus Drug
- Total-Body Irradiation Radiation
Procedure · Drug · Radiation
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, 2010
- Primary completion
- Oct 7, 2016
- Completion
- Jun 29, 2017
- Last update posted
- Apr 29, 2026
2010 – 2017
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80217-3364 | — |
| 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 | — |
| VA Puget Sound Health Care System | Seattle | Washington | 98101 | — |
| Fred Hutch/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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01231412, 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 Apr 29, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01231412 live on ClinicalTrials.gov.