Phase 2
N=100
Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT)
Graft-Versus-Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT00141739 ↗Enrolled (actual)
100
Serious AEs
25.0%
Results posted
Jun 2014
Primary outcome: Primary: The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) — 45; 18 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etanercept (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
45; 18 | — |
| SECONDARY Number of Patients Experiencing Etanercept Toxicity |
0; 5; 59; 24 | — |
| SECONDARY The Number of Patients That Experience Idiopathic Pulmonary Syndrome (IPS) |
1; 0 | — |
| SECONDARY Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients |
1.89; 1.1 | 0.001 sig |
| SECONDARY The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy. |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00141739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.