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

Information source: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft vs. Host Disease

Intervention: Ustekinumab (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Joseph Pidala, MD, MS, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Summary

To determine whether treatment with ustekinumab will alter the ratio of Treg/total CD4+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

Clinical Details

Official title: Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Treg/total CD4+ ratio

Secondary outcome: Incidence of Acute Graft vs. Host Disease

Detailed description: This is a comparative study to assess the biologic and clinical activity of the agent ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo) vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1: 1 scheme.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hematologic disorder requiring allogeneic hematopoietic cell transplantation

- Adequate vital organ function:

- Left ventricular ejection fraction (LVEF) >/= 45% by 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

Locations and Contacts

H Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 33612, United States
Additional Information

H. Lee Moffitt Cancer Center & Research Institute

Starting date: February 2013
Last updated: March 16, 2015

Page last updated: August 23, 2015

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