Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease

• Status: Completed
• Trial end date: 2018-06-14
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Gateway for Cancer Research
• Treatments: Everolimus; Sirolimus; Tacrolimus; Ustekinumab

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) < 3 times upper limit of normal values

• Creatinine clearance >/= 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