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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


Phase 2
1 Year
60 Years
Open (Enrolling)
Both
Graft-Versus-Host Disease

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

John E. Levine, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2004.008

NCT ID:

NCT00141739

Start Date:

August 2004

Completion Date:

August 2013

Related Keywords:

  • Graft-Versus-Host Disease
  • Stem Cell Transplantation
  • Graft-Versus-Host Disease
  • prophylaxis
  • Graft vs Host Disease

Name

Location

The University of MichiganAnn Arbor, Michigan  48109
Loyola University Medical Center, Cardinal Bernardin Cancer CenterMaywood, Illinois  60153