MedTrace Logo

Ibrutinib in Previously Untreated Binet Stage a Chronic Lymphocytic Leukemia with Risk of Disease Progression

NCT02863718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2024-12-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ibrutinib

Bruton's tyrosine kinase Inhibitor Ibrutinib 420mg daily

DRUG

Placebo

Placebo 420mg daily

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Petra Langerbeins, MD · German CLL Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2019-03-07
Completion
2022-07-11

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863718 on ClinicalTrials.gov