drugset / Trial / NCT02007044

Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

NCT02007044 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies ibrutinib with or without rituximab in treating patients with chronic lymphocytic leukemia that has come back after treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether ibrutinib is more effective with or without rituximab in treating chronic lymphocytic leukemia.

Timeline

Start
2013-12-06
Primary completion
2028-06-30
Completion
2028-06-30

Outcome

Missed primary endpoint

paper We conclude that the addition of rituximab to ibrutinib in relapsed and treatment-naive high-risk patients with CLL failed to show improvement in PFS. PMID 30530801 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous