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NCT03462719Phase 3ACTIVE 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)

Study 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).

Conditions
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions / Drugs
IbrutinibVenetoclaxChlorambucilObinutuzumabIbrutinib (as Subsequent Therapy)
View on ClinicalTrials.gov ↗
Sponsor
JNJ
Johnson & Johnson
Diversified Pharma
C51/100
Study Details
Enrollment211 participants
Primary Completion—
Lead SponsorJanssen Research & Development, LLC
Data Retrieved2026-04-11 02:55:31.550973+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 211 participants
Sponsor Catalyst Profile

Johnson & Johnson (JNJ) is the sponsoring company for this trial. BiotechSign currently grades this company C (51/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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