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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525407
First Posted: February 3, 2012
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marco Mielcarek, Fred Hutchinson Cancer Research Center
January 31, 2012
February 3, 2012
April 11, 2017
August 17, 2017
August 17, 2017
May 2012
September 2015   (Final data collection date for primary outcome measure)
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.
Grade 3-4 Acute GVHD [ Time Frame: First 100 days after transplant ]
A reduction in the cumulative incidence of acute GVHD from 15% to < 5% would represent a reasonable goal after hematopoietic cell transplant (HCT) with filgrastim (G-CSF)-mobilized blood cells and constitute study success.
Complete list of historical versions of study NCT01525407 on ClinicalTrials.gov Archive Site
  • 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.
  • Disease-free Survival [ Time Frame: 1 year after transplant ]
    Evaluated as Kaplan-Meier estimate in the patients/recipients.
  • 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.
  • Non-relapse Mortality [ Time Frame: At day 100 ]
    Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.
  • 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.
  • Overall Survival [ Time Frame: 1 year after transplant ]
    Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.
  • Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity [ Time Frame: Until completion of stem cell collection (on average 14 days) ]
  • Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy [ Time Frame: First 100 days after transplant ]
  • 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.
  • Grades II-IV acute and chronic GVHD [ Time Frame: First 100 days after transplant ]
  • Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy [ Time Frame: First 100 days after transplant ]
  • Chronic extensive GVHD [ Time Frame: First 100 days after transplant ]
  • Recurrent or Progressive Malignancy [ Time Frame: Up to 3 years ]
  • Non-relapse Mortality [ Time Frame: Day 100 and at 1 year after HCT ]
  • Disease-free Survival [ Time Frame: 1 year after transplant ]
  • Overall Survival [ Time Frame: 1 year after transplant ]
  • Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity [ Time Frame: Day -14 through stem cell collection ]
Not Provided
Not Provided
 
Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic 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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Malignant Neoplasm
  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    Undergo myeloablative allogeneic PBSC transplant
    Other Names:
    • allogeneic stem cell transplantation
    • HSC
    • HSCT
  • Drug: Atorvastatin Calcium
    Given PO
    Other Names:
    • CI-981
    • Lipitor
  • Procedure: Peripheral Blood Stem Cell Transplantation
    Undergo myeloablative allogeneic PBSC transplant
    Other Names:
    • PBPC transplantation
    • Peripheral Blood Progenitor Cell Transplantation
    • Peripheral Stem Cell Support
    • Peripheral Stem Cell Transplantation
Experimental: Supportive care (donor statin treatment)
Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Interventions:
  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
  • Drug: Atorvastatin Calcium
  • Procedure: Peripheral Blood Stem Cell Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2016
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01525407
2545.00
NCI-2011-03827 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2545.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01HL108307 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Marco Mielcarek, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Marco Mielcarek Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP