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

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ClinicalTrials.gov Identifier: NCT01525407
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marco Mielcarek, Fred Hutchinson Cancer Research Center

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
Enrollment 83

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donors Patients
Hide Arm/Group Description

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

Recipients of donor stem cells.
Period Title: Overall Study
Started 41 42
Completed 38 38
Not Completed 3 4
Reason Not Completed
Change in recipient treatment plan             2             2
Withdrawal by Subject             0             1
Transplant was delayed             0             1
Delay in Transplant             1             0
Arm/Group Title Donors Patients Total
Hide Arm/Group Description

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

Recipients of donor stem cells. Total of all reporting groups
Overall Number of Baseline Participants 38 38 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants 38 participants 76 participants
54
(22 to 64)
52
(24 to 69)
53
(22 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 76 participants
Female
17
  44.7%
16
  42.1%
33
  43.4%
Male
21
  55.3%
22
  57.9%
43
  56.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 76 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%
1.Primary Outcome
Title Grade 3-4 Acute GVHD
Hide Description Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
Time Frame First 100 days after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.21
(0.10 to 0.35)
2.Secondary Outcome
Title Chronic Extensive GVHD
Hide Description Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.
Time Frame 2 years post transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.51
(0.33 to 0.66)
3.Secondary Outcome
Title Disease-free Survival
Hide Description Evaluated as Kaplan-Meier estimate in the patients/recipients.
Time Frame 1 year after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: disease free survival probability
0.47
(0.34 to 0.66)
4.Secondary Outcome
Title Grades II-IV Acute GVHD
Hide Description Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.
Time Frame First 100 days after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.78
(0.61 to 0.89)
5.Secondary Outcome
Title Non-relapse Mortality
Hide Description Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.
Time Frame At day 100
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.13
(0.05 to 0.26)
6.Secondary Outcome
Title Non-relapse Mortality
Hide Description Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.
Time Frame At 1 year after HCT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.29
(0.15 to 0.44)
7.Secondary Outcome
Title Overall Survival
Hide Description Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.
Time Frame 1 year after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.55
(0.42 to 0.74)
8.Secondary Outcome
Title Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity
Hide Description [Not Specified]
Time Frame Until completion of stem cell collection (on average 14 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donors
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.3%
9.Secondary Outcome
Title Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Hide Description [Not Specified]
Time Frame First 100 days after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
5
  13.2%
10.Secondary Outcome
Title Recurrent or Progressive Malignancy
Hide Description Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients
Hide Arm/Group Description:
Recipients of donor stem cells.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.27
(0.14 to 0.42)
Time Frame Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier. Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patient Adverse Events Donor Adverse Events
Hide Arm/Group Description Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier. Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier.
All-Cause Mortality
Patient Adverse Events Donor Adverse Events
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patient Adverse Events Donor Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/38 (55.26%)      0/41 (0.00%)    
Blood and lymphatic system disorders     
Relapse *  1/38 (2.63%)  1 0/41 (0.00%)  0
Bleeding *  1/38 (2.63%)  1 0/41 (0.00%)  0
Gastrointestinal disorders     
Pneumotosis *  1/38 (2.63%)  1 0/41 (0.00%)  0
Nausea/Vomiting *  3/38 (7.89%)  3 0/41 (0.00%)  0
General disorders     
Multi-Organ Failure *  2/38 (5.26%)  2 0/41 (0.00%)  0
Immune system disorders     
GVHD *  7/38 (18.42%)  8 0/41 (0.00%)  0
EBV-PTLD *  1/38 (2.63%)  1 0/41 (0.00%)  0
Infections and infestations     
Fever/Infection *  9/38 (23.68%)  11 0/41 (0.00%)  0
Metabolism and nutrition disorders     
Metabolic Acidosis *  1/38 (2.63%)  1 0/41 (0.00%)  0
Hypercalcemia *  1/38 (2.63%)  1 0/41 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain *  1/38 (2.63%)  1 0/41 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury *  1/38 (2.63%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
DAH *  1/38 (2.63%)  1 0/41 (0.00%)  0
Pulmonary Emboli *  1/38 (2.63%)  1 0/41 (0.00%)  0
IPS *  1/38 (2.63%)  1 0/41 (0.00%)  0
ARDS *  1/38 (2.63%)  1 0/41 (0.00%)  0
Vascular disorders     
Dehydration *  1/38 (2.63%)  2 0/41 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patient Adverse Events Donor Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/41 (0.00%)    
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
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