Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01744912

Recruitment Status:

Terminated

Sponsor:

TG Therapeutics, Inc.

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There are 2 Locations for this study

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TG Therapeutics Investigational Trial Site
Huntsville Alabama, 35805, United States
TG Therapeutics Investigational Trial Site
Bethesda Maryland, 20817, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01744912

Recruitment Status:

Terminated

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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