Ublituximab + Ibrutinib in Select B-cell Malignancies

Phase 2CompletedNCT02013128

TG Therapeutics, Inc.66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia Mantle Cell Lymphoma

Interventions

UblituximabDRUG

Ublituximab (IV infusion)

IbrutinibDRUG

Ibrutinib oral daily dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Outcomes

Primary Outcomes

To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies

To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Time frame: 28 days (1 cycle of therapy)

Secondary Outcomes

Overall Response Rate

To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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