Clinical trial · Interventional
Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject 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 atorvastatin to the donor before transplant may prevent this from happening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Atorvastatin Calcium | Drug | — | UNRESOLVED |
| Peripheral Blood Stem Cell Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (donor statin treatment)
- description
- Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
- interventionNames
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Atorvastatin Calcium
- Procedure: Peripheral Blood Stem Cell Transplantation
Primary outcomes (1)
- measure
- Grade 3-4 Acute GVHD
- timeFrame
- First 100 days after transplant
- description
- Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
Secondary outcomes (9)
- measure
- Chronic Extensive GVHD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Human leukocyte antigen (HLA)-identical sibling donor * Myeloablative preparative regimen (i.e., \>= TBI 12.0 Gy, \>= busulfan (BU) 8.0 mg/kg PO, \>= BU 6.4 mg/kg intravenously (IV), \>= treosulfan 42 g/m\^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee * Transplantation of PBSC * Cyclosporine (CSP)-based postgrafting immunosuppression * Willingness to give informed consent * DONOR: Age \>= 18 years * DONOR: HLA genotypically identical sibling * DONOR: Willingness to give informed consent Exclusion Criteria: * Nonmyeloablative preparative regimen * Participation in an investigational study that has acute GVHD as the primary endpoint * The allogeneic PBSC donor has a contraindication to statin treatment * DONOR: Age \< 18 years * DONOR: Active liver disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels \> 2 times the upper limit of normal \[ULN\]) * DONOR: History of myopathy * DONOR: Hypersensitivity to atorvastatin * DONOR: Pregnancy * DONOR: Nursing mother * DONOR: Current serious systemic illness * DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals) * DONOR: Current use of statin drug * DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation * DONOR: Total creatinine kinase \> 2 times the ULN
References
Publications (0)
Data not yet available