drugset / Trial / NCT03609593

Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia

NCT03609593 ↗

Phase 2 Completed 42 enrolled Nicole Lamanna
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the efficacy of bendamustine and rituximab (BR) followed by venetoclax for 12 months. The total time on therapy is 15 months. Bendamustine and rituximab is a commonly used treatment for CLL. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. It is approved for patients with relapsed (the cancer has come back) or refractory (the cancer did not respond) CLL who harbor a deletion in the short arm of chromosome 17 \[del(17p)\]. When this drug is used by itself, many patients needed to be admitted to the hospital to monitor for a complication known as tumor lysis syndrome. This is an oncologic emergency that is caused by massive destruction of tumor cells with the release of large amounts of electrolytes and other molecules into the blood that can lead to renal failure and potentially death.

Timeline

Start
2018-11-12
Primary completion
2026-01-27
Completion
2026-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 50 mg/m2 —
Subject Bendamustine Small molecule 90 mg/m2 —
Subject Rituximab Monoclonal antibody 500 mg/m2 —
Subject Venetoclax Small molecule 400 mg Oral