Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
Public ClinicalTrials.gov record NCT01527045. 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
Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.
Study identification
- NCT ID
- NCT01527045
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 47 participants
Conditions and interventions
Conditions
- Aggressive Non-Hodgkin Lymphoma
- Blasts Under 5 Percent of Bone Marrow Nucleated Cells
- Chronic Lymphocytic Leukemia
- Loss of Chromosome 17p
- Myelodysplastic/Myeloproliferative Neoplasm
- Non-Hodgkin Lymphoma
- Prolymphocytic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Aggressive Adult Non-Hodgkin Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Hodgkin Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Plasma Cell Myeloma
- Recurrent Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
- Atorvastatin Calcium Drug
- Cyclosporine Drug
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Mycophenolate Mofetil Drug
- Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Peripheral Blood Stem Cell Transplantation Procedure
- Total-Body Irradiation Radiation
Drug · Other · Procedure + 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
- Sep 24, 2012
- Primary completion
- Sep 30, 2018
- Completion
- Mar 31, 2019
- Last update posted
- Jan 1, 2020
2012 – 2019
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01527045, 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 Jan 1, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01527045 live on ClinicalTrials.gov.