Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Etanercept

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.