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NCT01647971 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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