drugset / Trial / NCT04843904

Safe Accelerated Venetoclax Escalation in CLL

NCT04843904

Phase 1 Active not recruiting 40 enrolled Dana-Farber Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

This research study is trying to determine which patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely tolerate an accelerated, daily venetoclax dose ramp-up rather than the standard approved schedule (5-week dose ramp-up). The name of the study drug involved in this study is: * Venetoclax The following drugs may also be included in some participants treatment regimen: * Obinutuzumab * Rituximab

Timeline

Start
2021-04-14
Primary completion
2025-06-02
Completion
2030-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 400 mg Oral
Background Obinutuzumab Monoclonal antibody Intravenous
Background Rituximab Monoclonal antibody Intravenous