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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: Ublituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ublituximab<br>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. | Drug: Ublituximab<br>* Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation | Subjects will be followed for 4 weeks | 
| Maximum Tolerated Dose acceptable for participants | The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board | Subjects will be followed for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Efficacy will include overall response rate, duration of response and progression-free survival | Participants will be evaluated approximately every 8 - 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Rituxan, Relapsed, Refractory