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

NCT ID: NCT01744912

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-21
• Study Completion Date: 2014-02-07

Brief 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.

Detailed Description

The study was intended to be a Phase 1/2 study, however, the study was terminated early and the phase 2 portion was never initiated. A limited number of participants were enrolled in Phase 1 and no maximum tolerated dose (MTD) or Phase 2 dose was identified for the combination of ublituximab and lenalidomide. Thus, Phase 2 data and results are not available to be reported.

Conditions

Non-Hodgkins Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; B-cell Lymphomas; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Waldenstrom's Macroglobulinemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ublituximab + Lenalidomide

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.

Group Type: EXPERIMENTAL

Ublituximab

Intervention Type: DRUG

Ublituximab is a novel monoclonal antibody targeting CD20

Lenalidomide

Intervention Type: DRUG

Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects

Interventions

Ublituximab

Ublituximab is a novel monoclonal antibody targeting CD20

Intervention Type: DRUG

Lenalidomide

Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects

Intervention Type: DRUG

Other Intervention Names

TG-1101; Revlimid

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TG Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

TG Therapeutics Clinical Trials

Role: STUDY_DIRECTOR

TG Therapeutics, Inc.

Locations

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

TGTX 1101-102

Identifier Type: -

Identifier Source: org_study_id