Phase 2
N=30
Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
Graft vs. Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT01713400 ↗Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Sep 2015
Primary outcome: Primary: T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio — 13; 11 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ustekinumab (Drug); Placebo (Drug); Tacrolimus (TAC) (Drug); Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio |
13; 11 | — |
| SECONDARY Incidence of Acute Graft vs. Host Disease (AGVHD) |
33.3; 40.0 | — |
Summary
To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).
Eligibility Criteria
Inclusion Criteria
- Hematologic disorder requiring allogeneic hematopoietic cell transplantation
- Adequate vital organ function:
- Left ventricular ejection fraction (LVEF) >/= 45% by multigated acquisition (MUGA) scan
- FEV1, FVC, and diffusing lung capacity oxygenation (DLCO) >/= 50% of predicted values on pulmonary function tests
- Transaminases (AST, ALT) /= 50 cc/min.
- Performance status: Karnofsky Performance Status Score >/= 60%.
Exclusion Criteria
- Active infection not controlled with appropriate antimicrobial therapy
- HIV, hepatitis B, or hepatitis C infection
- Sorror's co-morbidity factors with total score > 3
- Important modification to co-morbidity index calculation: DLCO will not be included in assessment of pulmonary risk, excepting those with DLCO < 50%, who will merit a score of 3 and thereby be excluded from the trial.
- Anti-thymocyte globulin (ATG) as part of the conditioning regimen
- Cyclophosphamide as part of the conditioning regimens
Data sourced from ClinicalTrials.gov (NCT01713400). 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.