Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome

In brief

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 (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).

Key facts

Study ID

NCT01491958

Run by

Ohio State University Comprehensive Cancer Center

People needed

40

Starts

2011-12-10

Expected to finish

2016-06-27

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.