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

Descriptive Information
Brief Title † Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Official 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
Brief 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.
Detailed Description
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measure † Efficacy
Condition † Non-Hodgkins Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia Marginal Zone Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Primary Central Nervous System Lymphoma
Intervention † DrugUblituximab
Study Arms / Comparison Groups ublituximab Phase I: 4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with CLL or SLL will have infusions on Days 1, 8 and 15 of cycle 1 & 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 60
Start Date † August 2012
Completion Date December 2017
Primary Completion Date November 2017
Eligibility Criteria † 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 - 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01647971
Organization ID TGTX 1101-101
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † TG Therapeutics, Inc.
Collaborators ††
Investigators † Study Director: TG Therapeutics Clinical Trials, TG Therapeutics, Inc.
Information Provided By
Verification Date May 2017
First Received Date † July 17, 2012
Last Updated Date May 12, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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