Ublituximab + Ibrutinib in Select B-cell Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma

In brief

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.

Key facts

Study ID

NCT02013128

Run by

TG Therapeutics, Inc.

People needed

66

Starts

2014-01-06

Expected to finish

2015-12-01

Last updated by the study team

2022-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
• Refractory to or relapsed after at least 1 prior treatment regimen
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

You may not qualify if…

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
• Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma

Where it is running

• TG Therapeutics Investigational Trial Site — Huntsville, Alabama, United States
• TG Therapeutics Investigational Trial Site — Tucson, Arizona, United States
• TG Therapeutics Investigational Trial Site — Santa Barbara, California, United States
• TG Therapeutics Investigational Trial Site — Boulder, Colorado, United States
• TG Therapeutics Investigational Trial Site — Niles, Illinois, United States
• TG Therapeutics Investigational Trial Site — Urbana, Illinois, 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 — Portland, Oregon, United States
• TG Therapeutics Investigational Trial Site — Springfield, Oregon, United States
• TG Therapeutics Investigational Trial Site — Greenville, South Carolina, United States
• TG Therapeutics Investigational Trial Site — Memphis, Tennessee, United States
• TG Therapeutics Investigational Trial Site — Austin, Texas, United States
• TG Therapeutics Investigational Trial Site — Dallas, Texas, United States
• TG Therapeutics Investigational Trial Site — Tyler, Texas, United States
• TG Therapeutics Investigational Trial Site — Blacksburg, Virginia, United States
• TG Therapeutics Investigational Trial Site — Fairfax, Virginia, United States
• TG Therapeutics Investigational Trial Site — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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