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

Conditions

• Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ublituximab — DRUG
  Administered as an IV infusion
• Ibrutinib — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Jan 27, 2015

Status verified

Apr 2022

Primary completion

Apr 1, 2020

Completion

Apr 1, 2020

Study Design

Enrollment

126 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ublituximab + Ibrutinib
  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.
• Active Comparator: Ibrutinib
  Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 62 months ]

Locations (87)

Find similar trials in Huntsville, AL

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