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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome
Efficacy
Condition
Non-Hodgkins Lymphoma
Intervention
Ublituximab
Study Arms / Comparison Groups
ublituximab
Description: 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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (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
39
Start Date
July 19, 2012
Completion Date
May 2015
Primary Completion Date
May 2015
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
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
TG Therapeutics Clinical Trials, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01647971
Organization ID
TGTX 1101-101
Responsible Party
Sponsor
Study Sponsor
TG Therapeutics, Inc.
Study Sponsor
TG Therapeutics Clinical Trials, Study Director, TG Therapeutics, Inc.
Verification Date
November 2022