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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01744912
Collaborator
(none)
10
Enrollment
2
Locations
1
Arm
14.6
Actual Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 21, 2012
Actual Primary Completion Date :
Feb 7, 2014
Actual Study Completion Date :
Feb 7, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ublituximab + Lenalidomide

4 cohorts, with 3 - 6 patients per cohort, as follows: Cohort 1: Ublituximab 450 mg + Lenalidomide 10 mg Cohort 2: Ublituximab 450 mg + Lenalidomide 15 mg Cohort 3: Ublituximab 600 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1) Cohort 4: Ublituximab 900 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1) Ublituximab is an IV infusion on days 1, 8, and 15 of cycles 1 & 2 followed by a planned maintenance with a single infusion on day 1 of cycles 3 thru 6. Lenalidomide is taken orally on days 9 - 28 of cycle 1 followed by daily administration on Days 1 - 28 for cycles 2 thru 6. Non-hodgkins lymphoma patients may have up to a 7 day rest period (Days 21-28) in any cycle.

Drug: Ublituximab
Ublituximab is a novel monoclonal antibody targeting CD20
Other Names:
  • TG-1101

    • Drug: Lenalidomide
    Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
    Other Names:
  • Revlimid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose acceptable for participants [4 weeks]

      The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

    Secondary Outcome Measures

    1. Efficacy [After 8 weeks and then every 12 weeks]

      Efficacy will include overall response rate and duration of response

    Other Outcome Measures

    1. Pharmacokinetic profile including Peak Plasma Concentration (Cmax) [Up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Huntsville Alabama United States 35805
    2 TG Therapeutics Investigational Trial Site Bethesda Maryland United States 20817

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    • Study Director: TG Therapeutics Clinical Trials, TG Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01744912
    Other Study ID Numbers:
    • TGTX 1101-102
    First Posted:
    Dec 7, 2012
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by TG Therapeutics, Inc.
    Lymphoma
    monoclonal antibody
    immunomodulatory agent
    ublituximab
    lenalidomide
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoma, Mantle-Cell
    Waldenstrom Macroglobulinemia
    Lenalidomide

    Study Results

    No Results Posted as of May 11, 2022