Finding studies
Finding studies
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The Ohio State University Comprehensive Cancer Center
CONTACT
Lead
Jonathan Brammer
With
PRIMARY OBJECTIVES: I. Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL). II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL. SECONDARY OBJECTIVES: PRIMARY OBJECTIVES: I. Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL). II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL. SECONDARY OBJECTIVES: I. Survival (progression free survival \[PFS\]/overall survival \[OS\]) of patients with ruxolitinib maintenance (auto-SCT, allo-SCT, whole cohort). II. Determine the safety and feasibility of ruxolitinib maintenance post-SCT. III. Determine the effect of ruxolitinib on the cumulative incidence (CI) of grade II-IV acute GVHD (alloSCT), chronic extensive GVHD, non-relapse mortality (NRM) (auto-SCT and allo-SCT). EXPLORATORY OBJECTIVES: I. Determine the effect of maintenance ruxolitinib compared to matched historical controls using the Center for International Blood and Marrow Transplant Research (CIBMTR) registry. II. Determine the effect of ruxolitinib on immune modulation and reconstitution post-allo-SCT and upon disease relapse. OUTLINE: Starting day +35 to day +120 post-SCT, patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)-computed tomography (CT) scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression. After completion of study treatment, patients are followed up at 18 and 24 months then yearly until 5 years and at progression.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
