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Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies 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, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B-cell Lymphomas, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Waldenstrom's Macroglobulinemia

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Trial Information

Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy


Inclusion Criteria:



- Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic
Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

- Patients must have received at least one prior line of therapy with an anti-CD20
antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing
regimen

- Measurable or evaluable Disease

- Eastern Cooperative Oncology Group performance status 0, 1 or 2

- Patients ineligible for high dose or combination chemotherapy + stem cell transplant

- No active or chronic infection of Hepatitis B or C and no history of HIV based on
negative serology

- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®

Exclusion Criteria:

- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study
entry

- Prior autologous or allogeneic stem cell transplantation within 6 months of study
entry

- History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human
chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide
or thalidomide

- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness that would limit compliance with study
requirements

- History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months
prior to Day 1 of Cycle 1

- 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:

Maximum Tolerated Dose acceptable for participants

Outcome Description:

The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

Outcome Time Frame:

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 1101-102

NCT ID:

NCT01744912

Start Date:

December 2012

Completion Date:

February 2014

Related Keywords:

  • Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • B-Cell Lymphomas
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
  • Waldenstrom's Macroglobulinemia
  • Lymphoma
  • monoclonal antibody
  • immunomodulatory agent
  • ublituximab
  • lenalidomide
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

TG Therapeutics Investigational Trial SiteHuntsville, Alabama  35805
TG Therapeutics Investigational Trial SiteAthens, Georgia  30607
TG Therapeutics Investigational Trial SiteBethesda, Maryland  20817