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

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.

NCT Number	NCT05478512
Lead Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions	High Risk CLL, Chronic Lymphocytic Leukemia
Enrollment	78 participants
Start Date	2023-07-21
Primary Completion	2026-05 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-03-17