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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744912
• Other study ID #: TGTX 1101-102
• Status: Terminated
• Phase: Phase 1
• Start date: November 21, 2012
• Est. completion date: February 7, 2014

Study information

• Verified date: May 2022
• Source: TG Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 7, 2014
• Est. primary completion date: February 7, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ublituximab
Ublituximab is a novel monoclonal antibody targeting CD20
• Lenalidomide
Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects

Locations

Country	Name	City	State
United States	TG Therapeutics Investigational Trial Site	Bethesda	Maryland
United States	TG Therapeutics Investigational Trial Site	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic profile including Peak Plasma Concentration (Cmax)		Up to 6 months
Primary	Maximum Tolerated Dose acceptable for participants	The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board	4 weeks
Secondary	Efficacy	Efficacy will include overall response rate and duration of response	After 8 weeks and then every 12 weeks