Ublituximab + Ibrutinib in Select B-cell Malignancies

TG Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Ibrutinib; Drug: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013128

UTX-IB-104

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Ublituximab + ibrutinib

Experimental group

Description:

Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose

Treatment:

Drug: Ibrutinib

Drug: Ublituximab