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

Completed · Phase 2 · Has a placebo group

Conditions studied: Graft vs. Host Disease

In brief

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).

Key facts

Study ID

NCT01713400

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

54

Starts

2013-02-25

Expected to finish

2018-06-14

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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