Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)
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Purpose
This is a clinical trial to see if the addition of etanercept to standard preventative medicines helps in preventing two major complications of hematopoietic stem cell transplantation (HSCT): decrease the rate of acute graft-vs-host disease (GVHD) and the risk of death.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft-Versus-Host Disease |
Drug: Etanercept |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
- To determine whether etanercept given prophylactically, along with a standard GVHD prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- Evaluation of, the toxicity profile of etanercept when given in this clinical context [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- the effect of etanercept on the incidence of idiopathic pulmonary syndrome (IPS) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- the effect of etanercept on plasma and cellular cytokine levels after HSCT [ Time Frame: 100 days ] [ Designated as safety issue: No ]
- and the impact of tumor necrosis factor (TNF) polymorphisms on response to therapy. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GVHD prophylaxis
GVHD prophylaxis with etanercept
|
Drug: 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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients must be between 1 and 60 years of age and be a candidate for myeloablative donor stem cell transplantation
- Patients must receive myeloablative regimen using fludarabine and busulfan
- For related donors: The donor and recipient must have a 5/6 match at the HLA A, B, and DRB1 loci. [Patients with a 6/6 related donor are NOT eligible.] For unrelated donors: The donor and recipient must have a 5/6 or 6/6 match at the HLA A, B, and DRB1 loci.
- The typing level to define a match at the A and B locus must be at the level of mid-resolution DNA typing. The acceptable level to define a match at DRB1 will be by allelic typing by high resolution DNA sequencing.
- Any disease for which myeloablative transplantation is appropriate is eligible except: Progressive or poorly controlled malignancies for which the likelihood of durable disease control [i.e., patients expected to have at least 6 months PFS from date of transplant] is <25%.
Exclusion Criteria:
- Not a candidate for myeloablative conditioning regimen using the current BMT program clinical guidelines.
- Patient has a 6/6 HLA-matched related donor
- Karnofsky or Lansky performance status of < 60% at the time of admission for HSCT
- Patients with evidence of HIV infection or other opportunistic infection including but not limited to tuberculosis and histoplasmosis.
- Any conditions, in the opinion of the transplant team such as substance abuse, or severe personality disorder that would keep the patients from complying with the needs of the protocol and would markedly increase the morbidity and mortality from the procedure.
- Pregnancy.
- T-cell depleted allograft
- Patients with documented infections, not responding well to antibiotic therapy.
- Patients with bacteremia.
Contacts and Locations| 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 |
More Information
No publications provided by University of Michigan Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00141739 History of Changes |
| Other Study ID Numbers: | UMCC 2004.008 |
| Study First Received: | August 30, 2005 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
Stem Cell Transplantation Graft-Versus-Host Disease prophylaxis |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013