Clinical trial NCT01744912: Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
Official title: A 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Hodgkins Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
B-cell Lymphomas
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Waldenstrom's Macroglobulinemia
Keywords: Lymphoma
monoclonal antibody
immunomodulatory agent
ublituximab
lenalidomide
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: After 8 weeks and then every 12 weeks
Other outcomes:
measure: Pharmacokinetic profile including Peak Plasma Concentration (Cmax)
timeFrame: Up to 6 months
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Bethesda
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
Study officials:
affiliation: TG Therapeutics, Inc.
name: TG Therapeutics Clinical Trials
role: STUDY_DIRECTOR
References: