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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
Results First Submitted: April 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Malignant Neoplasm
Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Atorvastatin Calcium
Procedure: Peripheral Blood Stem Cell Transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Donors

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

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant

Atorvastatin Calcium: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant

Patients Recipients of donor stem cells.

Participant Flow:   Overall Study
    Donors   Patients
STARTED   41   42 
COMPLETED   38   38 
NOT COMPLETED   3   4 
Change in recipient treatment plan                2                2 
Withdrawal by Subject                0                1 
Transplant was delayed                0                1 
Delay in Transplant                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Donors

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

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant

Atorvastatin Calcium: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant

Patients Recipients of donor stem cells.
Total Total of all reporting groups

Baseline Measures
   Donors   Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   38   76 
Age 
[Units: Years]
Median (Full Range)
 54 
 (22 to 64) 
 52 
 (24 to 69) 
 53 
 (22 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  44.7%      16  42.1%      33  43.4% 
Male      21  55.3%      22  57.9%      43  56.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      4  10.5%      4  10.5%      8  10.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      28  73.7%      27  71.1%      55  72.4% 
More than one race      0   0.0%      1   2.6%      1   1.3% 
Unknown or Not Reported      6  15.8%      6  15.8%      12  15.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade 3-4 Acute GVHD   [ Time Frame: First 100 days after transplant ]

2.  Secondary:   Chronic Extensive GVHD   [ Time Frame: 2 years post transplant ]

3.  Secondary:   Disease-free Survival   [ Time Frame: 1 year after transplant ]

4.  Secondary:   Grades II-IV Acute GVHD   [ Time Frame: First 100 days after transplant ]

5.  Secondary:   Non-relapse Mortality   [ Time Frame: At day 100 ]

6.  Secondary:   Non-relapse Mortality   [ Time Frame: At 1 year after HCT ]

7.  Secondary:   Overall Survival   [ Time Frame: 1 year after transplant ]

8.  Secondary:   Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity   [ Time Frame: Until completion of stem cell collection (on average 14 days) ]

9.  Secondary:   Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy   [ Time Frame: First 100 days after transplant ]

10.  Secondary:   Recurrent or Progressive Malignancy   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Marco Mielcarek
Organization: Fred Hutchinson Cancer Research Center
phone: 2066672827
e-mail: mmielcar@fredhutch.org



Responsible Party: Marco Mielcarek, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01525407     History of Changes
Other Study ID Numbers: 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 )
First Submitted: January 31, 2012
First Posted: February 3, 2012
Results First Submitted: April 11, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017