Overview

A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk Chronic Lymphatic Leukemia

Status:
Not yet recruiting

Trial end date:
2027-01-01

Target enrollment:

Participant gender:

Summary

This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation or complex karyotype).

Phase:

Phase 3

Details

Lead Sponsor:

German CLL Study Group

Collaborator:

AstraZeneca

Treatments:

Acalabrutinib
Obinutuzumab
Venetoclax