Overview

This trial is active, not recruiting.

Conditions non-hodgkins lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, b-cell lymphomas, marginal zone lymphoma, mantle cell lymphoma, waldenstrom's macroglobulinemia
Treatments ublituximab, lenalidomide
Phase phase 1/phase 2
Target CD20
Sponsor TG Therapeutics, Inc.
Start date December 2012
End date February 2014
Trial size 60 participants
Trial identifier NCT01744912, TGTX 1101-102

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
4 cohorts, with 3 - 6 patients per cohort, as follows: Cohort 1: Ublituximab 450 mg + Lenalidomide 10 mg Cohort 2: Ublituximab 450 mg + Lenalidomide 15 mg Cohort 3: Ublituximab 600 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1) Cohort 4: Ublituximab 900 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1) Ublituximab is an IV infusion on days 1, 8, and 15 of cycles 1 & 2 followed by a planned maintenance with a single infusion on day 1 of cycles 3 thru 6. Lenalidomide is taken orally on days 9 - 28 of cycle 1 followed by daily administration on Days 1 - 28 for cycles 2 thru 6. Non-hodgkins lymphoma patients may have up to a 7 day rest period (Days 21-28) in any cycle.
ublituximab TG-1101
Ublituximab is a novel monoclonal antibody targeting CD20
lenalidomide Revlimid
Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects

Primary Outcomes

Measure
Maximum Tolerated Dose acceptable for participants
time frame: 4 weeks

Secondary Outcomes

Measure
Efficacy
time frame: After 8 weeks and then every 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..