This phase II trial studies how well ruxolitinib phosphate works in treating patients with diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed) or that does not respond to treatment (refractory) after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Assess the overall response rate (ORR) of subjects with relapsed diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) who are relapsed or refractory to front-line treatment and ineligible for stem cell transplantation or have recurrent disease after stem cell transplantation to oral ruxolitinib (ruxolitinib phosphate). SECONDARY OBJECTIVES: I. Evaluate safety of oral ruxolitinib in subjects with DLBCL and PTCL. II. Determine progression-free survival (PFS), duration of response, and overall response (OS) in subjects with DLBCL and PTCL. TERTIARY OBJECTIVES: I. Explore the relationship between responses to oral ruxolitinib and alterations in gene expression profiling (GEP) signatures as well as biomarker immunophenotypic changes related to JAK2/STAT3, NF-kB, PI3K/AKT, and mTOR pathways. II. Evaluate potential effect of oral ruxolitinib exposure on JAK2/STAT3 pathway inhibition in serial tumor samples. OUTLINE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Correlative studies
Given PO
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Overall Response Rate
Number of patients achieving overall response rate
Time frame: 24 weeks
Overall Survival (OS)
The Kaplan-Meier method will be used to estimate the median OS time and its 95% CI.
Time frame: From the date of start of treatment to date of death due to any cause, assessed up to 60 months
Progression-free Survival
The Kaplan-Meier method will be used to estimate the median PFS time and its 95% CI.
Time frame: From the date of start of treatment to the date of event defined as the first documented progression or death due to any cause, assessed up to 60 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.