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Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy

NCT01647971•TG Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Relapsed or Refractory B-cell Lymphoma
•Measurable or Evaluable Disease
•Previously treated with at least one line of rituximab or a rituximab based therapy
•Patients ineligible for high dose or combination chemotherapy + stem cell transplant
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
•No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology

Exclusion Criteria

•Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
•Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
•History of severe hypersensitivity or anaphylaxis to prior rituximab
•Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
•Pregnant women

Locations (8)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Jonesboro, Arkansas, United States

TG Therapeutics Investigational Trial Site

Athens, Georgia, United States

TG Therapeutics Investigational Trial Site

Macon, Georgia, United States

TG Therapeutics Investigational Trial Site

Bethesda, Maryland, United States

TG Therapeutics Investigational Trial Site

Morristown, New Jersey, United States

TG Therapeutics Investigational Trial Site

New York, New York, United States

TG Therapeutics Investigational Trial Site

Memphis, Tennessee, United States

Key Dates

Start Date

July 19, 2012

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

November 21, 2022

Enrollment

39

ACTUAL participants

Conditions

Non-Hodgkins LymphomaB-cell LymphomaWaldenstrom's MacroglobulinemiaMarginal Zone LymphomaChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Primary Central Nervous System Lymphoma

Interventions

Ublituximab

DRUG

Sponsors

Lead Sponsor

TG Therapeutics, Inc.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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