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Phase II Study Evaluating the Safety and Efficacy of Atorvastatin for the Prophylaxis of Acute Graft-versus-host Disease in Patients Undergoing Matched Sibling Hematopoietic Stem Cell Transplantation


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

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Trial Information

Phase II Study Evaluating the Safety and Efficacy of Atorvastatin for the Prophylaxis of Acute Graft-versus-host Disease in Patients Undergoing Matched Sibling Hematopoietic Stem Cell Transplantation


This is a phase II study of atorvastatin for the prophylaxis of acute GVHD in patients
undergoing matched-sibling allogeneic HSCT. This study will explore a two-pronged acute GVHD
prophylaxis strategy, consisting of pre-treating consenting sibling donors with atorvastatin
before stem cell collection, followed by the addition of atorvastatin to
methotrexate/tacrolimus-based GVHD prophylaxis.

Inclusion Criteria


DONOR ELIGIBILITY CRITERIA:

1. Donors must be ≥18 years of age, and willing/able to provide informed consent.

2. Female donors of child-bearing potential should have a negative pregnancy test, and
must be not be breast feeding.

3. Adequate hepatic function with bilirubin, AST and ALT < 2.5 x upper limit of normal.

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

5. Adequate cardiac function as per institutional guidelines.

6. Donors with positive HIV serologies are not eligible.

7. No clinical evidence of uncontrolled active bacterial, viral or fungal infection at
the time of stem cell mobilization.

8. Donors must have a Karnofsky performance score of ≥60.

9. Donors with history of intolerance or allergic reactions with atorvastatin will not
be eligible. Hypersensitivity to any component of atorvastatin.

10. 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 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.

PATIENT ELIGIBILITY CRITERIA:

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

2. 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).

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

4. Patient must provide informed consent.

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

6. Bilirubin <2mg/dl and AST and ALT < 3 x normal; and absence of hepatic cirrhosis.

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

8. DLCO (diffusion capacity; corrected for hemoglobin) ≥ 50% of predicted.

9. Karnofsky performance status > 70.

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

11. Patients with positive HIV serology are not eligible.

12. No evidence of active uncontrolled bacterial, viral or fungal infection at the time
of transplant conditioning.

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

14. 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.

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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

100 days

Safety Issue:

No

Principal Investigator

Mehdi Hamadani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University

Authority:

United States: Institutional Review Board

Study ID:

WVU11010

NCT ID:

NCT01175148

Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Graft Vs Host Disease
  • HSCT
  • HPC
  • HCT
  • BMT
  • lipitor
  • atorvastatin
  • HMG-CoA Reductase Inhibitor
  • Hematopoietic stem cell transplant
  • allogeneic transplant
  • GVHD
  • graft-versus-host-disease
  • Graft vs Host Disease
  • Graft vs Host Disease

Name

Location

West Virginia University Hospitals Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506