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OpenTrials
Completed

NCT Number: NCT01647971

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

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.

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Key information

Conditions

Non-Hodgkins Lymphoma B-cell Lymphoma Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia (CLL) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Central Nervous System Lymphoma Recurrence Small Lymphocytic Lymphoma (SLL) Vascular Diseases Waldenstrom Macroglobulinemia Waldenstrom's Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ublituximab

Drug

Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Subjects will be followed for 4 weeks

    Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation

  2. Maximum Tolerated Dose acceptable for participants

    Time frame: Subjects will be followed for 4 weeks

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

Secondary outcomes

  1. Efficacy

    Time frame: Participants will be evaluated approximately every 8 - 12 weeks

    Efficacy will include overall response rate, duration of response and progression-free survival

Other outcomes

  1. Pharmacokinetic profile including Peak Plasma Concentration (Cmax)" or "Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2012
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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