Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Graft-Versus-Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Etanercept
Intervention description: 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.
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 1 Year
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Stem Cell Transplantation; Graft-Versus-Host Disease; prophylaxis

Summary:

      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.
    

Eligibility criteria:

        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.