Status:
COMPLETED
Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Phase II trial evaluating the safety \& efficacy of Atorvastatin for prophylaxis of Acute Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human leukocyte antigen...
Detailed Description
The study is a single-arm phase II single institutional trial evaluating the safety and efficacy of atorvastatin for the prophylaxis of acute GVHD in patients with hematological malignancies undergoin...
Eligibility Criteria
Inclusion
- Donor Eligibility Criteria
- The donor must be at least 18 years of age, and willing/able to provide informed consent. Complete medication list will be reviewed for potential negative interaction with atorvastatin.
- The donor must be an HLA-matched sibling or relative.
- Syngeneic donors are not eligible.
- Female donors of child-bearing potential should have a negative pregnancy test, and must not be breast feeding.
- Bilirubin, AST and ALT must be \< 2 x normal; and absence of hepatic fibrosis/cirrhosis.
- Adequate renal function as defined by a serum creatinine clearance of ≥ 40% of normal calculated by Cockcroft-Gault equation.
- Adequate cardiac function with no history of congestive heart failure, uncontrolled atrial fibrillation or ventricular tachyarrhythmias.
- Patient Eligibility Criteria
- Have hematologic malignancy requiring allogeneic HSCT, have adequate organ function, a serologic (or higher resolution) 6/6 class I human leukocyte antigen (HLA)-A and B and molecular class II DRB1 matched related donor, and are able to give informed consent.
- Patients \> 18 and ≤ 65 years with comorbidity score ≤ 3 will be eligible for myeloablative conditioning (MAC), while patients \> 65 years of age, those with previous history of autologous transplantation, or high comorbidity index (\>3) will be eligible for reduced intensity conditioning (RIC) transplantation .
- All patients must have at least one 6/6 HLA-matched sibling donor.
- Patient must provide informed consent
- Patients must have left ventricular ejection fraction \> 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure.
- Bilirubin must be \< 2 x normal; and absence of hepatic fibrosis/cirrhosis.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be \<2 x normal; and absence of hepatic fibrosis/cirrhosis.
- Serum creatinine clearance of ≥40% of normal calculated by Cockcroft-Gault equation.
- Forced expiratory volume in one second (FEV1)and diffusion capacity; corrected for hemoglobin(DLCO) ≥ 50% and 40% of predicted respectively.
- Karnofsky performance status \> 70.
- A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted.
- No HIV infection. Patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies.
- No evidence of active bacterial, viral or fungal infection at the time of transplant conditioning.
- No active alcohol or substance abuse within 6 months of study entry.
- Prior allogeneic transplant is acceptable.
- No history of intolerance or allergic reactions with atorvastatin or other statins.
- Patients who have previously been taking atorvastatin or any other statin will be eligible as long as there is no contraindication to switch to atorvastatin 40mg/day in the opinion of the treating physician.
Exclusion
- Patients undergoing a T-cell depleted allogeneic transplantation will not be eligible.
- Patients receiving another investigational drug are not eligible unless cleared by Principal Investigator. Patients with prior malignancies except resected basal cell carcinoma, treated carcinoma in-situ, or other hematologic diseases for which allogeneic HSCT is a treatment strategy, are not eligible. Cancer treated with curative intent \< 5 years previously will not be allowed unless approved by the Principal Investigator.
Key Trial Info
Start Date :
December 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01491958
Start Date
December 10 2011
End Date
June 27 2016
Last Update
January 23 2018
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210