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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01744912
Other study ID # TGTX 1101-102
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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