Status:
ACTIVE_NOT_RECRUITING
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Inde...
Eligibility Criteria
Inclusion
- Adult participants who are: (a) greater than or equal to (\>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:
- Cumulative Illness Rating Scale (CIRS) score \> 6
- Creatinine clearance (CrCl) estimated less than (\<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Measurable nodal disease (by computed tomography \[CT\]), defined as at least one lymph node \> 1.5 centimeter (cm) in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (\<=) 2
- Active CLL/SLL requiring treatment per the iwCLL criteria
Exclusion
- Prior anti-leukemic therapy for CLL or SLL
- Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of \>10 percent (%) variable allele frequency (VAF)
- Major surgery within 4 weeks of first dose of study treatment
- Known bleeding disorders (example, von Willebrand's disease or hemophilia)
- Central nervous system (CNS) involvement or suspected Richter's syndrome
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2029
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT03462719
Start Date
April 17 2018
End Date
April 5 2029
Last Update
December 22 2025
Active Locations (87)
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1
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
2
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
3
Novant Health
Charlotte, North Carolina, United States, 28204
4
Institut - Jules Bordet
Anderlecht, Belgium, 1070