Phase 2
Completed N=83
Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
Malignant Neoplasm
Source: ClinicalTrials.gov NCT01525407 ↗
Enrolled (actual)
83
Serious AEs
26.6%
Results posted
Aug 2017
Primary outcomePrimary: Grade 3-4 Acute GVHD — 0.21 probability
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grade 3-4 Acute GVHD |
0.21 | — |
| SECONDARY Chronic Extensive GVHD |
0.51 | — |
| SECONDARY Disease-free Survival |
0.47 | — |
| SECONDARY Grades II-IV Acute GVHD |
0.78 | — |
| SECONDARY Non-relapse Mortality |
0.29 | — |
| SECONDARY Overall Survival |
0.55 | — |
| SECONDARY Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity |
3 | — |
| SECONDARY Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy |
5 | — |
| SECONDARY Recurrent or Progressive Malignancy |
0.27 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01525407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.