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Active Not Recruiting
NCT03462719
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)
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 211
Sponsor: Janssen Research & Development, LLC
Location: Norton Cancer Institute Louisville Kentucky
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 Independent Review Committee (IRC).
Eligibility Criteria
Inclusion Criteria:
* 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:
1. Cumulative Illness Rating Scale (CIRS) score \> 6
2. Creatinine clearance (CrCl) estimated less than (\ 1.5 centimeter (cm) in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (\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
Source: ClinicalTrials.gov (NCT03462719). StuddyBuddy aggregates publicly available trial information.
