drugset / Trial / NCT03422393

Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib

NCT03422393

Phase 1 Active not recruiting 24 enrolled Michael Choi Pharmacyclics LLC. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate whether the combination of venetoclax and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL that is not responding or no longer responding to treatment with ibrutinib alone. The study will evaluate whether this regimen can reduce the amount of cancerous cells in your body. If you agree, you will receive ibrutinib at a dose of up to 840 mg a day by mouth, as well as venetoclax. Although both of these agents are approved by the FDA for the treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered experimental.

Timeline

Start
2018-05-01
Primary completion
2024-08
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral
Subject Ibrutinib Small molecule 840 mg Oral
Subject Venetoclax Small molecule 400 mg Oral