Atorvastatin for the Prophylaxis of Acute GVHD in Patients Undergoing Matched Sibling Allogeneic Transplantation

Phase 2

Completed

• Conditions: Graft vs Host Disease
• Interventions: Drug: Atorvastatin calcium (Lipitor)

• Registration Number: NCT01175148
• Lead Sponsor: West Virginia University

Brief Summary

Atorvastatin for prevention of acute GVHD

Detailed Description

This is a phase II study of atorvastatin for the prophylaxis of acute GVHD in patients undergoing matched-sibling allogeneic HSCT. This study will explore a two-pronged acute GVHD prophylaxis strategy, consisting of pre-treating consenting sibling donors with atorvastatin before stem cell collection, followed by the addition of atorvastatin to methotrexate/tacrolimus-based GVHD prophylaxis.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-11-04
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Results First Posted: 2017-06-07
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recipient - Atorvastatin to prevent GVHD	Atorvastatin calcium (Lipitor)	Atorvastatin calcium (Lipitor) will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD. This is the experimental arm for outcome measures.
Donor - Atorvastatin conditioning for donors	Atorvastatin calcium (Lipitor)	Sibling donors will start taking Atorvastatin calcium (Lipitor) orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.

Primary Outcome Measures

Name	Time	Method
Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients	100 days post transplant	Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients

Trial Locations

Locations (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center; 🇺🇸 Morgantown, West Virginia, United States