This trial is active, not recruiting.

Conditions non-hodgkins lymphoma, b-cell lymphoma, waldenstrom's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, primary central nervous system lymphoma
Treatment ublituximab
Phase phase 1/phase 2
Target CD20
Sponsor TG Therapeutics, Inc.
Start date August 2012
End date October 2016
Trial size 60 participants
Trial identifier NCT01647971, TGTX 1101-101


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
Ublituximab is a novel monoclonal antibody targeting CD20

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Subjects will be followed for 4 weeks
Maximum Tolerated Dose acceptable for participants
time frame: Subjects will be followed for 4 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..