Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL — VIS  

Chronic Lymphocytic Leukemia Clinical Trial

Official title: Front-line Venetoclax and Obinutuzumab Combination Followed by Venetoclax or Venetoclax and Zanubrutinib Combination in Patients With Residual Disease: a Minimal Residual Disease (MRD) Tailored Treatment for Young Patients With High-risk CLL

Status Recruiting

Clinical Trial Summary

Multicentric phase 2 study for previously untreated high-risk CLL patients. Patients will receive 6 courses of the Venetoclax + Obinutuzumab combination.

• Patients with stable disease or a response (CR/PR) with uMRD in the PB and BM at cycle 9 will continue treatment with Venetoclax single agent until cycle 13 and then stop treatment.

• Patients with stable disease or a response (CR/PR) with evidence of residual disease in the PB and/or BM at cycle 9 will continue treatment with Venetoclax and Zanubrutinib combination until cycle 21.

then, Patients with uMRD in the PB and BM at cycle 21 will stop treatment whereas patients with residual disease in the PB and/or BM at cycle 21 will discontinue Venetoclax and continue Zanubrutinib until disease progression.

Clinical Trial Description

This is a multicentric phase 2 study for previously untreated high-risk CLL patients.

A. The study treatment will consist of 6 courses of the Venetoclax + Obinutuzumab combination.

B. Patients with stable disease or a response (CR/PR) with undetectable MRD (uMRD) in the PB and BM at cycle 9 will continue treatment with Venetoclax single agent until cycle 13 and then stop treatment.

C. Patients with stable disease or a response (CR/PR) with evidence of residual disease in the PB and/or BM at cycle 9 will continue treatment with Venetoclax and Zanubrutinib (VenZan) combination until cycle 21.

c1. Patients with uMRD in the PB and BM at cycle 21 will stop treatment. c2. Patients with residual disease in the PB and/or BM at cycle 21 will discontinue Venetoclax and continue Zanubrutinib until disease progression.

In all patients with uMRD, MRD will be monitored during the follow-up. Patients with a response with uMRD in the PB and BM who subsequently develop an MRD positivity will not be treated. A new treatment will start at the time of clinical disease progression according to the iwCLL criteria. ;

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell

• NCT number: NCT05478512
• Study type: Interventional
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: paola Fazi
• Phone: 0670390526
• Email: p.fazi@gimema.it
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2023
• Completion date: July 2027