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)
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT03462719
This study evaluates progression-free survival in CLL/SLL patients using ibrutinib plus venetoclax versus chlorambucil plus obinutuzumab. Eligible adults are \>=65 or 18-64 with specific health criteria. Interventions include ibrutinib, venetoclax, chlorambucil, and obinutuzumab, with specific dosing schedules. Participants must have measurable nodal disease and meet iwCLL treatment criteria.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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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
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Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
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Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2
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Active CLL/SLL requiring treatment per the iwCLL criteria
Exclusion Criteria
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Norton Cancer Institute | 40207 | Louisville | Kentucky |
| John Theurer Cancer Center | 07601 | Hackensack | New Jersey |
| Novant Health | 28204 | Charlotte | North Carolina |
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