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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Primary Central Nervous System Lymphoma

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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