Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

• Patients must have received at least one prior line of therapy with an anti-CD20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing regimen

• Measurable or evaluable Disease

• Eastern Cooperative Oncology Group performance status 0, 1 or 2

• Patients ineligible for high dose or combination chemotherapy + stem cell transplant

• No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology

• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®

Exclusion Criteria:

• Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry

• Prior autologous or allogeneic stem cell transplantation within 6 months of study entry

• History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide

• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements

• History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to Day 1 of Cycle 1

• Pregnant women