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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744912
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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
Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma B-cell Lymphomas Marginal Zone Lymphoma Mantle Cell Lymphoma Waldenstrom's Macroglobulinemia Drug: Ublituximab Drug: Lenalidomide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

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 Name: TG-1101

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

Primary Outcome Measures :
  1. Maximum Tolerated Dose acceptable for participants [ Time Frame: 4 weeks ]
    The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 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) [ Time Frame: Up to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)
  • Patients 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
  • Patients 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744912

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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Maryland
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States, 20817
Sponsors and Collaborators
TG Therapeutics, Inc.
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Study Director: TG Therapeutics Clinical Trials TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc. Identifier: NCT01744912    
Other Study ID Numbers: TGTX 1101-102
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by TG Therapeutics, Inc.:
monoclonal antibody
immunomodulatory agent
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents