A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanubrutinib — DRUG
  Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
• Bendamustine — DRUG
  Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.
• Rituximab — DRUG
  Administered intravenously (IV) at a dose of 375 mg/m\^2 on day 0 of cycle 1, and at a dose of 500 mg/m\^2 on day 1 of cycles 2 to 6
• Venetoclax — DRUG
  400 mg tablets administered orally once daily.

Study Details

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

Key Dates

Start date

Oct 31, 2017

Status verified

Feb 2026

Primary completion

May 7, 2021

Completion

Oct 31, 2027

Study Design

Enrollment

590 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Bendamustine + Rituximab
  Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)
• Experimental: Cohort 1: Zanubrutinib
  Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)
• Experimental: Cohort 1a (China only): Bendamustine + Rituximab
  Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)
• Experimental: Cohort 1a (China only): Zanubrutinib
  Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)
• Experimental: Cohort 2: Zanubrutinib
  Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)
• Experimental: Cohort 3: Venetoclax + Zanubrutinib
  Approximately 110 participants, 50 without del17p and 60 with del\[17p\] or TP53 mutation will receive zanubrutinib plus venetoclax; Participants will also receive zanubrutinib starting on Cycle 1 Day 1 then daily for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Participants will receive venetoclax starting Cycle 4 Day 1 according to a 5-week dose-up schedule then daily until unacceptable toxicity, disease progression, or for a maximum of 24 cycles. Each cycle is 28 days. (Arm D)

Primary Outcome Measure

Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) [ Time Frame: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) ]

Locations (18)

Find similar trials in Augusta, GA

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