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Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01491958
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yvonne Efebera, Ohio State University Comprehensive Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Myelodysplastic Syndrome
Interventions: Drug: atorvastatin
Drug: Tacrolimus
Drug: methotrexate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who are candidates for HSCT using HLA matched related donors were eligible to be enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Donors Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.

Participant Flow:   Overall Study
    Patients   Donors
STARTED   40   40 
COMPLETED   40   40 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Patients Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Donor Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
Total Total of all reporting groups

Baseline Measures
   Patients   Donor   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Median (Full Range)
 51 
 (27 to 71) 
 50 
 (25 to 68) 
 51 
 (25 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  50.0%      20  50.0%      40  50.0% 
Male      20  50.0%      20  50.0%      40  50.0% 
Region of Enrollment 
[Units: Patients]
     
United States   40   40   80 


  Outcome Measures

1.  Primary:   Percentage of Participants With Grades II to IV aGVHD at Day +100 of Atorvastatin Administration   [ Time Frame: Up through day 100 following transplant ]

2.  Secondary:   Safety of Atorvastatin in Transplant Recipients in Terms of Adverse Events and Toxicities.   [ Time Frame: Patients: Baseline, weekly for 9 weeks and then on days 84, 91-100, 180 and 365. Donors: at apheresis and then 30 days later. ]

3.  Secondary:   Time to Neutrophil and Platelet Engraftment   [ Time Frame: weekly for 12 weeks, 100 days, 6 months, and 12 months ]

4.  Secondary:   Percentage of Patients With Chronic Graft Versus Host Disease (cGVHD)   [ Time Frame: up 1 year post transplant ]

5.  Secondary:   Non Relapse Mortality (NRM) at One Year   [ Time Frame: up to 12 months post transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Yvonne Efebera, M.D
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3196
e-mail: Yvonne.Efebera@osumc.edu



Responsible Party: Yvonne Efebera, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01491958     History of Changes
Other Study ID Numbers: OSU-11004
NCI-2011-03590 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Submitted: December 9, 2011
First Posted: December 14, 2011
Results First Submitted: May 23, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018