Completed

Atorvastatin, Micro-dose Methotrexate and Tacrolimus for Acute Graft-versus-host Disease Prevention Post Allogeneic Hematopoietic Cell Transplantation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Atorvastatin calcium

+ Atorvastatin calcium

Drug
Who is being recruted

Immune System Diseases

+ Graft vs Host Disease

From 18 to 75 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorMehdi Hamadani
Last updated: May 15, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: January 20, 2014

Actual date on which the first participant was enrolled.

Acute graft-versus-host disease (GVHD) is one of the most frequent complications after allogeneic hematopoietic stem cell transplantation (HSCT).(1) It develops in 30-75% of recipients of allogeneic HSCT depending on the degree of histocompatibility between the donor and the recipient, number of T-cells in the graft, recipient's age and GVHD prophylactic regimen used. (2-4) Novel strategies designed to effectively prevent the development of this life threatening complication of allogeneic transplantation are urgently needed.

NCT01665677
Principal SponsorMehdi Hamadani
Last updated: May 15, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesGraft vs Host Disease

Criteria

13 inclusion criteria required to participate
A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted
Adequate renal function as defined by a serum creatinine clearance of >= 40% of normal calculated by Cockcroft-Gault equation
All patients must have at least one suitable human leukocyte antigen (HLA)-matched sibling or unrelated donor according to transplant center's guidelines (for selection of appropriate sibling donor)
Bilirubin <= 2 x the upper limit of normal (ULN) and aspartate aminotransferase (AST), and alanine aminotransferase (ALT) <= 3 x ULN; and absence of hepatic cirrhosis. For patients with Gilbert's syndrome, bilirubin <= 3 x ULN is permitted
Show More Criteria
5 exclusion criteria prevent from participating
Evidence of active bacterial, viral or fungal infection at the time of transplant conditioning
History of intolerance or allergic reactions with atorvastatin will not be eligible
Receiving conditioning regimens containing anti-thymocyte globulin, and/or campath
Uncontrolled arrhythmias or uncontrolled New York Heart Association class III-IV heart failure
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Atorvastatin will be administered at a dose of 40 mg 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 until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.

Group II

Experimental
Atorvastatin will be administered at a dose of 40 mg 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 until the patient develops grade II-IV acute GVHD, extensive chronic GVHD, or any grade 3-4 toxicity related to atorvastatin.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, United StatesOpen West Virginia University Hospitals Mary Babb Randolph Cancer Center in Google Maps

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, United States
Completed2 Study Centers