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Phase II Study of Atorvastatin, Micro-dose Methotrexate and Tacrolimus Administered Only to Transplant Recipients for the Prophylaxis of Acute Graft-versus-host Disease Following Allogeneic Hematopoietic Cell Transplantation

Phase 2
18 Years
75 Years
Open (Enrolling)
Graft vs Host Disease

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Trial Information

Phase II Study of Atorvastatin, Micro-dose Methotrexate and Tacrolimus Administered Only to Transplant Recipients for the Prophylaxis of Acute Graft-versus-host Disease Following Allogeneic Hematopoietic Cell Transplantation

Acute graft-versus-host disease (GVHD) is one of the most frequent complications after
allogeneic hematopoietic stem cell transplantation (HSCT) (1). It develops in 30-75% of
recipients of allogeneic HSCT depending on the degree of histocompatibility between the
donor and the recipient, number of T-cells in the graft, recipient's age and GVHD
prophylactic regimen used (2-4). Novel strategies designed to effectively prevent the
development of this life threatening complication of allogeneic transplantation are urgently

Inclusion Criteria

Patient Eligibility Criteria:

- Patients with a history of a hematological malignancy or bone marrow failure syndrome
suitable for allogeneic stem cell transplantation in the opinion of treating
transplant physician.

- Patients aged 18-75 years of age are eligible. Patients with age > 18 and ≤ 50 years
will be eligible for myeloablative conditioning (MAC), while patients > 50 years of
age, or those with previous history of autologous transplantation, high hematopoietic
cell transplant comorbidity index (HCT-CI) score (>2), and baseline diagnosis of
hodgkin's lymphoma, chronic lymphocytic leukemia and follicular lymphoma will be
suitable for reduced intensity conditioning (RIC) transplantation (however intensity
of conditioning regimen will remain at the discretion of treating physician).

- All patients must have at least one suitable human leukocyte antigen (HLA)-matched
sibling or unrelated donor according to transplant center's guidelines (for selection
of appropriate sibling donor).

- Patient must provide informed consent.

- Left ventricular ejection fraction ≥ 40%. No uncontrolled arrhythmias or uncontrolled
New York Heart Association class III-IV heart failure.

- Bilirubin ≤ 2 x the upper limit of normal (ULN) and aspartate aminotransferase (AST),
and alanine aminotransferase (ALT) ≤ 3 x ULN; and absence of hepatic cirrhosis. For
patients with Gilbert's syndrome, bilirubin ≤ 3 x ULN is permitted.

- Adequate renal function as defined by a serum creatinine clearance of ≥ 40% of normal
calculated by Cockcroft-Gault equation.

- DLCOcor (carbon monoxide diffusing capacity; corrected for hemoglobin) or forced
expiratory volume at one second (FEV1) or DL/VA ≥ 40% of predicted (a pulmonary
function test).

- Karnofsky performance status > 70.

- A negative pregnancy test will be required for all women of child bearing potential.
Breast feeding is not permitted.

- Patients with positive HIV serology are eligible.

- No evidence of active bacterial, viral or fungal infection at the time of transplant

- Patients with history of intolerance or allergic reactions with atorvastatin will not
be eligible.

- Patients who have previously been taking atorvastatin or any other statin drug will
be eligible as long as there is no contraindication to switch to atorvastatin
(40mg/day) in the opinion of the treating physician.

- Patients undergoing a T-cell depleted allogeneic transplantation will not be

- Patients receiving conditioning regimens containing antithymocyte globulin, and/or
campath will not be eligible.

- Method of stem-cell collection from the sibling donor will be at the discretion of
the treating physician. Although it is anticipated that majority of sibling donors
will undergo Granulocyte colony-stimulating factor(G-CSF) induced stem cell
mobilization; however donors undergoing bone marrow harvest or stem cell mobilization
with experimental agents (e.g. plerixafor) will remain eligible for the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Determine efficacy of atorvastatin/tacrolimus/methotrexate in preventing GVHD

Outcome Description:

Determine the efficacy of an atorvastatin/tacrolimus/methotrexate regimen in preventing grade II-IV acute GVHD in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT)

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Mehdi Hamadani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University


United States: Institutional Review Board

Study ID:

WVU 011012



Start Date:

September 2012

Completion Date:

December 2015

Related Keywords:

  • Graft Vs Host Disease
  • Graft vs Host Disease
  • GVHD
  • Allogeneic hematopoietic stem cell transplantation
  • HSCT
  • Atorvastatin
  • Graft vs Host Disease



West Virginia University Hospitals Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506