A Phase 2 Multicenter, Investigator Initiated Study of Oral Ruxolitinib Phosphate for the Treatment of Relapsed or Refractory Diffuse Large B-cell and Peripheral T-cell Non-Hodgkin Lymphoma
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.
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.
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-κB, BCR, PI3K/AKT, and mTOR pathways.
II. Evaluate potential effect of oral ruxolitinib exposure on JAK2/STAT3 pathway inhibition
in serial tumor samples.
Patients receive ruxolitinib phosphate (oral JAK inhibitor INCB18424) orally (PO) twice
daily (BID). Courses repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients achieving overall response rate
after 24 weeks
Julie M Vose, MD
University of Nebraska
United States: Food and Drug Administration
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|University of Texas, MD Anderson Cancer Center||Houston, Texas 77030|