NCT02013128
Completed
Phase 1
A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Overview
- Phase
- Phase 1
- Intervention
- Ublituximab
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Ublituximab + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Intervention: Ublituximab
Ublituximab + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Intervention: Ibrutinib
Outcomes
Primary Outcomes
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
Time Frame: 28 days (1 cycle of therapy)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary Outcomes
- Overall Response Rate(Up to 1 year)
Study Sites (1)
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