Clinical trial NCT01647971: Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Keywords: Lymphoma
Rituxan
Relapsed
Refractory
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Subjects will be followed for 4 weeks
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: Subjects will be followed for 4 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: Participants will be evaluated approximately every 8 - 12 weeks
Other outcomes:
measure: 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)
timeFrame: Up to 6 months
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Jonesboro
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Athens
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Macon
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Bethesda
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Morristown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Memphis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
Study officials:
affiliation: TG Therapeutics, Inc.
name: TG Therapeutics Clinical Trials
role: STUDY_DIRECTOR
References: