Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Completed · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT01647971
- Run by
- TG Therapeutics, Inc.
- People needed
- 39
- Starts
- 2012-07-19
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2022-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- TG Therapeutics Investigational Trial Site — Huntsville, Alabama, United States
- TG Therapeutics Investigational Trial Site — Jonesboro, Arkansas, United States
- TG Therapeutics Investigational Trial Site — Athens, Georgia, United States
- TG Therapeutics Investigational Trial Site — Macon, Georgia, United States
- TG Therapeutics Investigational Trial Site — Bethesda, Maryland, United States
- TG Therapeutics Investigational Trial Site — Morristown, New Jersey, United States
- TG Therapeutics Investigational Trial Site — New York, New York, United States
- TG Therapeutics Investigational Trial Site — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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