Ibrutinib in Previously Untreated Binet Stage A Chronic Lymphocytic Leukemia With Risk of Disease Progression

Sponsor
German CLL Study Group
Study ID
NCT02863718
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Bruton's tyrosine kinase Inhibitor Ibrutinib 420mg daily
  • Placebo — DRUG
    Placebo 420mg daily

Study Details

This is a prospective, multicenter, randomized, placebo-controlled, double-blind phase III study that compares the efficacy and safety of oral ibrutinib in previously untreated Binet stage A CLL patients without treatment indication according to iwCLL guidelines but risk of early disease progression. For event-free survival (EFS), an improvement from 24 months for untreated intermediate or (very) high risk CLL to 48 months for subjects treated with ibrutinib is considered clinically relevant. Ibrutinib / placebo is administered continuously orally until symptomatic disease progression, unacceptable toxicity, or voluntary treatment withdrawal, whichever occurs first.

Key Dates

Start date
Apr 30, 2014
Status verified
Nov 2022
Primary completion
Mar 7, 2019
Completion
Jul 11, 2022

Study Design

Enrollment
515 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Watch & wait
    Watch \& wait
  • Placebo Comparator: Placebo 420 mg/d
    Placebo 420mg/d
  • Active Comparator: Ibrutinib 420mg/d
    Ibrutinib 420mg/d

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: randomization until progression, initiation of subsequent treatment for CLL or death by any cause, whichever occurs first, assessed for at at least 60 months ]

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