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NCT Number: NCT01525407

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

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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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Hospitals and Clinics, Stanford, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic hematopoietic stem cell transplantation

Procedure

Undergo myeloablative allogeneic PBSC transplant

Other names: allogeneic stem cell transplantation, HSC, HSCT

Atorvastatin calcium

Drug

Given PO

Other names: CI-981, Lipitor

peripheral blood stem cell transplantation

Procedure

Undergo myeloablative allogeneic PBSC transplant

Other names: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

Primary outcomes

  1. Grade 3-4 Acute GVHD

    Time frame: First 100 days after transplant

    Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.

Secondary outcomes

  1. Chronic Extensive GVHD

    Time frame: 2 years post transplant

    Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.

  2. Disease-free Survival

    Time frame: 1 year after transplant

    Evaluated as Kaplan-Meier estimate in the patients/recipients.

  3. Grades II-IV Acute GVHD

    Time frame: First 100 days after transplant

    Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.

  4. Non-relapse Mortality

    Time frame: At day 100

    Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.

  5. Non-relapse Mortality

    Time frame: At 1 year after HCT

    Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.

  6. Overall Survival

    Time frame: 1 year after transplant

    Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.

  7. Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity

    Time frame: Until completion of stem cell collection (on average 14 days)

  8. Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy

    Time frame: First 100 days after transplant

  9. Recurrent or Progressive Malignancy

    Time frame: Up to 3 years

    Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 3, 2012
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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