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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01744912
First received: December 5, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose acceptable for participants [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board


Secondary Outcome Measures:
  • Efficacy [ Time Frame: After 8 weeks and then every 12 weeks ] [ Designated as safety issue: No ]
    Efficacy will include overall response rate and duration of response


Other Outcome Measures:
  • Pharmacokinetic profile including Peak Plasma Concentration (Cmax) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2012
Study Completion Date: October 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744912

Locations
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.
Investigators
Study Director: TG Therapeutics Clinical Trials TG Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01744912     History of Changes
Other Study ID Numbers: TGTX 1101-102
Study First Received: December 5, 2012
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by TG Therapeutics, Inc.:
Lymphoma
monoclonal antibody
immunomodulatory agent
ublituximab
lenalidomide

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 21, 2014