Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant
Public ClinicalTrials.gov record NCT01251575. 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 Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Multi-Center Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant 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 together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.
Study identification
- NCT ID
- NCT01251575
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 77 participants
Conditions and interventions
Conditions
- Adult Acute Lymphoblastic Leukemia
- Adult Acute Myeloid Leukemia
- Adult Diffuse Large B-Cell Lymphoma
- Adult Myelodysplastic Syndrome
- Adult Non-Hodgkin Lymphoma
- Aggressive Non-Hodgkin Lymphoma
- Childhood Acute Lymphoblastic Leukemia
- Childhood Acute Myeloid Leukemia
- Childhood Diffuse Large B-Cell Lymphoma
- Childhood Myelodysplastic Syndrome
- Childhood Non-Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia in Remission
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Hematopoietic and Lymphoid Cell Neoplasm
- Mantle Cell Lymphoma
- Plasma Cell Myeloma
- Prolymphocytic Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Refractory Chronic Lymphocytic Leukemia
- T-Cell Prolymphocytic Leukemia
- Waldenstrom Macroglobulinemia
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Hodgkin Lymphoma
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Cyclosporine Drug
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Mycophenolate Mofetil Drug
- Peripheral Blood Stem Cell Transplantation Procedure
- Sirolimus Drug
- Total-Body Irradiation Radiation
Procedure · Drug · Other + 1 more
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
- Nov 30, 2010
- Primary completion
- Nov 22, 2018
- Completion
- Feb 10, 2019
- Last update posted
- Dec 8, 2019
2010 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01251575, 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 Dec 8, 2019 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01251575 live on ClinicalTrials.gov.