Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia

Phase 3 Active, not recruiting NCT03737981

Condition	Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase	Phase 3
Sponsor	National Cancer Institute (NCI)
Status	Active, not recruiting
Enrollment	465 participants
Interventions	Ibrutinib, Obinutuzumab, Observation Activity, Venetoclax
Start date	Jan 31, 2019
Completion date	Jan 17, 2025
Results posted	Feb 2, 2026

Summary

This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.

Progression-free Survival (PFS)

5 years · proportion of participants w/out event

Arm I (Ibrutinib, Obinutuzumab)	0.59 proportion of participants w/out event
Arm II (Ibrutinib, Obinutuzumab, Venetoclax)	0.68 proportion of participants w/out event

p-value	0.2414
Hazard Ratio (HR)	0.89 (95% CI 0.64–1.24)

Open in BENITIONS View on ClinicalTrials.gov

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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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