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

NCT01744912 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: TGTX 1101-102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose acceptable for participants

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

  4 weeks

Secondary Outcomes (1)

• Efficacy

  After 8 weeks and then every 12 weeks

Other Outcomes (1)

• Pharmacokinetic profile including Peak Plasma Concentration (Cmax)

  Up to 6 months

Study Arms (1)

Ublituximab + Lenalidomide

EXPERIMENTAL

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; Drug: Lenalidomide

Interventions

Ublituximab DRUG

Ublituximab is a novel monoclonal antibody targeting CD20

Also known as: TG-1101

Ublituximab + Lenalidomide

Lenalidomide DRUG

Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects

Also known as: Revlimid

Ublituximab + Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®

You may not qualify if:

• 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

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

Study Sites (2)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, 35805, United States

Location

TG Therapeutics Investigational Trial Site

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Lymphoma

Interventions

ublituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• TG Therapeutics Clinical Trials

  TG Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: November 21, 2012
• Primary Completion: February 7, 2014
• Study Completion: February 7, 2014
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)