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

Primary Purpose

Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ublituximab
Lenalidomide
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma focused on measuring Lymphoma, monoclonal antibody, immunomodulatory agent, ublituximab, lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ublituximab + Lenalidomide

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy
Efficacy will include overall response rate and duration of response

Full Information

First Posted
December 5, 2012
Last Updated
May 5, 2022
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01744912
Brief Title
Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
November 21, 2012 (Actual)
Primary Completion Date
February 7, 2014 (Actual)
Study Completion Date
February 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B-cell Lymphomas, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Waldenstrom's Macroglobulinemia
Keywords
Lymphoma, monoclonal antibody, immunomodulatory agent, ublituximab, lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ublituximab + Lenalidomide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
Ublituximab is a novel monoclonal antibody targeting CD20
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose acceptable for participants
Description
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
Efficacy will include overall response rate and duration of response
Time Frame
After 8 weeks and then every 12 weeks
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic profile including Peak Plasma Concentration (Cmax)
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TG Therapeutics Clinical Trials
Organizational Affiliation
TG Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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