Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) (GENUINE)

TG Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Ublituximab; Drug: Ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02301156

UTX-IB-301

Details and patient eligibility

About

This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR [complete response] + PR [partial response]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
• At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion criteria

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
• Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
• Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Ublituximab + Ibrutinib

Experimental group

Description:

Participants will receive ublituximab intravenous (IV) infusion, up to 150 milligrams (mg) once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 62 months along with ibrutinib 420 mg capsules, orally, once daily (QD) in each 28-day cycle for up to 62 months.

Treatment:

Drug: Ibrutinib

Drug: Ublituximab

Ibrutinib

Active Comparator group

Description:

Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.

Treatment:

Drug: Ibrutinib