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

Marginal Zone Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647971
• Other study ID #: TGTX 1101-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 19, 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2022
• Source: TG Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ublituximab
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

Locations

Country	Name	City	State
United States	TG Therapeutics Investigational Trial Site	Athens	Georgia
United States	TG Therapeutics Investigational Trial Site	Bethesda	Maryland
United States	TG Therapeutics Investigational Trial Site	Huntsville	Alabama
United States	TG Therapeutics Investigational Trial Site	Jonesboro	Arkansas
United States	TG Therapeutics Investigational Trial Site	Macon	Georgia
United States	TG Therapeutics Investigational Trial Site	Memphis	Tennessee
United States	TG Therapeutics Investigational Trial Site	Morristown	New Jersey
United States	TG Therapeutics Investigational Trial Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic profile including Peak Plasma Concentration (Cmax)" or "Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC)		Up to 6 months
Primary	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
Primary	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	Efficacy	Efficacy will include overall response rate, duration of response and progression-free survival	Participants will be evaluated approximately every 8 - 12 weeks