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Phase II Trial Evaluating the Safety and Efficacy of Atorvastatin for the Prophylaxis of Acute Graft Versus Host Disease(GVHD) in Patients With Hematological Malignancies Undergoing HLA-Matched Related Donor Hematopoietic Stem Cell Transplantation (HSCT)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Trial Evaluating the Safety and Efficacy of Atorvastatin for the Prophylaxis of Acute Graft Versus Host Disease(GVHD) in Patients With Hematological Malignancies Undergoing HLA-Matched Related Donor Hematopoietic Stem Cell Transplantation (HSCT)


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 undergoing HLA matched related donor HSCT. This study will explore a
two-pronged acute GVHD prophylaxis strategy, consisting of pre-treating consenting related
donors with atorvastatin before stem cell mobilization and collection, followed by
atorvastatin plus methotrexate/tacrolimus-based GVHD prophylaxis in transplant recipient
patients.


Inclusion Criteria:



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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of atorvastatin added to standard GVHD prophylaxis regimen with tacrolimus and methotrexate, in reducing the incidence of grade II-IV acute GVHD.

Outcome Time Frame:

Up through day 100 following transplant

Safety Issue:

No

Principal Investigator

Yvonne Efebera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-11004

NCT ID:

NCT01491958

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • AML
  • ALL
  • MDS
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location

Ohio State UniversityColumbus, Ohio  43210