Tampa, Florida 33612

  • Graft vs. Host Disease

Purpose:

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).


Study summary:

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.


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


NCT ID:

NCT01713400


Primary Contact:

Principal Investigator
Joseph Pidala, MD, MS
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 22, 2021

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