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
18 Years
N/A
Both
Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Primary Central Nervous System Lymphoma
Trial Information
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
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
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Outcome Description:
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Outcome Time Frame:
Subjects will be followed for 4 weeks
Safety Issue:
No
Principal Investigator
TG Therapeutics Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
TG Therapeutics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
TGTX 1101-101
NCT ID:
NCT01647971
Start Date:
August 2012
Completion Date:
December 2013
Related Keywords:
- Non-Hodgkins Lymphoma
- B-Cell Lymphoma
- Waldenstrom's Macroglobulinemia
- Marginal Zone Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Primary Central Nervous System Lymphoma
- Lymphoma
- Rituxan
- Relapsed
- Refractory
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Waldenstrom Macroglobulinemia
- Lymphoma, B-Cell
- Lymphoma, B-Cell, Marginal Zone
Name | Location |
|---|---|
| TG Therapeutics Investigational Trial Site | Huntsville, Alabama 35805 |
| TG Therapeutics Investigational Trial Site | New York, New York 10022 |
| TG Therapeutics Investigational Trial Site | Athens, Georgia 30607 |
| TG Therapeutics Investigational Trial Site | Bethesda, Maryland 20817 |
| TG Therapeutics Investigational Trial Site | Morristown, New Jersey 07962 |
| TG Therapeutics Investigational Trial Site | Memphis, Tennessee 38120 |
