Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 3 Active, not recruiting NCT02048813

Condition	Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase	Phase 3
Sponsor	National Cancer Institute (NCI)
Status	Active, not recruiting
Enrollment	529 participants
Interventions	Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study
Start date	Mar 10, 2014
Completion date	Oct 24, 2018
Results posted	Aug 14, 2023

Summary

This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Progression-free Survival (PFS) Rate at 3 Years

Assessed every 3 months until progression up to 4 years and 8 months · Proportion of participants

Arm A (Ibrutinib, Rituximab)	0.894 Proportion of participants
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)	0.729 Proportion of participants

p-value	<.001
Hazard Ratio (HR)	0.35 (95% CI 0.22–0.56)

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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