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Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

NCT04608318 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 897

Last updated 2026-04-30

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL.

Conditions

  • Chronic Lymphoid Leukemia

Interventions

BIOLOGICAL

Ibrutinib

Cycles 1 - X: 420 mg daily, d1-28 p.o.

BIOLOGICAL

Venetoclax

Arm VG Cycle 1: 20 mg (2 tabl. at 10 mg), d22-28 p.o. Cycle 2: 50 mg (1 tabl. at 50 mg), d1-7; 100 mg (1 tabl. at 100 mg), d8-14; 200 mg (2 tabl. at 100 mg), d15-21; 400 mg (4 tabl. at 100 mg), d22-28 p.o. Cycles 3-12: 400 mg (4 tabl. at 100 mg), d1-28 p.o. Arm VI Cycle 4: 20 mg (2 tabl. at 10 mg), d1-7; 50 mg (1 tabl. at 50 mg), d8-14; 100 mg (1 tabl. at 100 mg), d15-21; 200 mg (2 tabl. at 100 mg), d22-28 p.o. Cycles 5-15: 400 mg (4 tabl. at 100 mg), d1-28 p.o.

BIOLOGICAL

Obinutuzumab

Cycle 1: (100 mg, d1 + 900 mg, d2) or 1000 mg, d1; 1000 mg, d8 + d15 i.v. Cycle 2 - 6: 1000 mg, d1 i.v.

Sponsors & Collaborators

  • Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)

    collaborator UNKNOWN

  • Nordic CLL Study Group (NCLLSG)

    collaborator UNKNOWN

  • Swiss Group for Clinical Cancer Research (SAKK)

    collaborator UNKNOWN

  • Cancer Trials Ireland

    collaborator NETWORK

  • Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA)

    collaborator UNKNOWN

  • Grupo Español de Leucemia Linfocítica Crónica (GELLC)

    collaborator OTHER_GOV

  • The Israeli CLL Study Group (ICLLSG)

    collaborator UNKNOWN

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Othman Al-Sawaf, Dr. med. · German CLL Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04608318 on ClinicalTrials.gov