Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Addition of Etanercept to Standard GVHD Prophylaxis in Patients Undergoing a Full Intensity Allogeneic Hematopoietic Stem Cell Transplant for the Prevention of Transplant Related Complications|
- The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
In order to determine whether etanercept, given prophylactically along with a standard Graft Versus Host Disease (GVHD) prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT), the incidence of grades 2-4 and grades 3-4 GVHD were calculated.
GVHD can be clinically graded as 0, I, II, III, or IV. Definition of grades are:
Grade 0 - No stage 1-4 of any organ Grade I - Stage 1-2 rash and no liver or gut involvement Grade II - Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gastrointestinal involvement Grade III - Stage 0-3 skin, with STage 2-3 liver, or Stage 2-3 gastrointestinal involvement Grade IV - Stage 4 skin, liver, or gastrointestinal involvement
- Number of Patients Experiencing Etanercept Toxicity [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]Toxicity of etanercept was evaluated by the following: the number of patients experiencing allergic reactions, the number of patients that discontinued etanercept early, the number of patients experiencing bacteremia, and the number of patients experiencing viral reactivations.
- The Effect of Etanercept on the Incidence of Idiopathic Pulmonary Syndrome (IPS) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients [ Time Frame: Day+7, post transplant ] [ Designated as safety issue: No ]The effect of etanercept on plasma cytokine levels after Hematopoietic Stem Cell Transplantation (HSCT) was analyzed. Tumor Necrosis Factor Receptor 1 (TNFR1) ratios (TNFR1 posttransplantation day+7 / TNFR1pretransplantation at Day+7 were calculated. Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.
- The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: GVHD prophylaxis
GVHD prophylaxis with etanercept
Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant.
Other Name: Enbrel
This is a clinical trial to see if the addition of etanercept helps in preventing two major complications of hematopoietic stem cell transplantation (HSCT). The main objective will be to see whether the addition of etanercept to standard preventative medicines will decrease the rate of acute graft-vs-host disease (GVHD) and the risk of death by 100 days following allogeneic HSCT from volunteer donors.
GVHD is a common complication following a bone marrow transplant from another donor. GVHD occurs after transplant when the donor's blood cells recognize parts of the body as foreign. During this process, chemicals called cytokines are released that may damage certain body tissues, including the gut, liver and skin. Some of the main effects can include red skin rash, diarrhea, sometimes with blood, and yellow jaundice. It can range from mild to life threatening and often requires admission to the hospital for treatment. The standard treatment for acute GVHD is a combination of steroids and another drug that suppress the immune system, such as tacrolimus or cyclosporine.
Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing damage to your tissue. The purpose of etanercept is to help improve the response to standard treatment for GVHD. Previous studies have shown that less than 50% of patients respond fully to GVHD treatment. Without a good response, patients often have a prolonged treatment for this disease, often involving hospitalization and sometimes even death. Etanercept (Enbrel) will be added to the standard treatment to see if we can lower the rate of GVHD and the risk of death from GVHD by blocking TNF.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141739
|United States, Illinois|
|Loyola University Medical Center, Cardinal Bernardin Cancer Center|
|Maywood, Illinois, United States, 60153|
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||John E. Levine, MD, MS||The University of Michigan Comprehensive Cancer Center|