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

Phase 1

Completed

• Conditions: 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
• Interventions: Drug: Ublituximab

• Registration Number: NCT01647971
• Lead Sponsor: TG Therapeutics, Inc.

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

Not available

Study Timeline

• Study First Submitted: 2012-07-17
• Study Start: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Disposition First Submitted: 2022-10-21
• Disposition First Submitted QC: 2022-10-21
• Disposition First Posted: 2022-10-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ublituximab	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 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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
Maximum Tolerated Dose acceptable for participants	Subjects will be followed for 4 weeks	The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

Secondary Outcome Measures

Name	Time	Method
Efficacy	Participants will be evaluated approximately every 8 - 12 weeks	Efficacy will include overall response rate, duration of response and progression-free survival

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Memphis, Tennessee, United States