B-cell Lymphomas, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Non-Hodgkins Lymphoma, Small Lymphocytic Lymphoma, Waldenstrom's Macroglobulinemia
Conditions
Keywords
Lymphoma, monoclonal antibody, immunomodulatory agent, ublituximab, lenalidomide
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.
Interventions
DRUGUblituximab
Ublituximab is a novel monoclonal antibody targeting CD20
DRUGLenalidomide
Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose acceptable for participants | 4 weeks | The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | After 8 weeks and then every 12 weeks | Efficacy will include overall response rate and duration of response |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile including Peak Plasma Concentration (Cmax) | Up to 6 months |
Countries
United States
Outcome results
None listed