Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-02-29

Brief Summary

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This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (donor statin treatment)

Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.

Group Type EXPERIMENTAL

Allogeneic Hematopoietic Stem Cell Transplantation

Intervention Type PROCEDURE

Undergo myeloablative allogeneic PBSC transplant

Atorvastatin Calcium

Intervention Type DRUG

Given PO

Peripheral Blood Stem Cell Transplantation

Intervention Type PROCEDURE

Undergo myeloablative allogeneic PBSC transplant

Interventions

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Allogeneic Hematopoietic Stem Cell Transplantation

Undergo myeloablative allogeneic PBSC transplant

Intervention Type PROCEDURE

Atorvastatin Calcium

Given PO

Intervention Type DRUG

Peripheral Blood Stem Cell Transplantation

Undergo myeloablative allogeneic PBSC transplant

Intervention Type PROCEDURE

Other Intervention Names

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allogeneic stem cell transplantation HSC HSCT CI-981 Lipitor PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation

Eligibility Criteria

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Inclusion Criteria

* Human leukocyte antigen (HLA)-identical sibling donor
* Myeloablative preparative regimen (i.e., \>= TBI 12.0 Gy, \>= busulfan (BU) 8.0 mg/kg PO, \>= BU 6.4 mg/kg intravenously (IV), \>= treosulfan 42 g/m\^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
* Transplantation of PBSC
* Cyclosporine (CSP)-based postgrafting immunosuppression
* Willingness to give informed consent
* DONOR: Age \>= 18 years
* DONOR: HLA genotypically identical sibling
* DONOR: Willingness to give informed consent

Exclusion Criteria

* Nonmyeloablative preparative regimen
* Participation in an investigational study that has acute GVHD as the primary endpoint
* The allogeneic PBSC donor has a contraindication to statin treatment
* DONOR: Age \< 18 years
* DONOR: Active liver disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels \> 2 times the upper limit of normal \[ULN\])
* DONOR: History of myopathy
* DONOR: Hypersensitivity to atorvastatin
* DONOR: Pregnancy
* DONOR: Nursing mother
* DONOR: Current serious systemic illness
* DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
* DONOR: Current use of statin drug
* DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
* DONOR: Total creatinine kinase \> 2 times the ULN

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No