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

PHASE2RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2027

Conditions
High Risk CLLChronic Lymphocytic Leukemia
Interventions
DRUG

VenObi+Ven or VenObi+VenZan

"Patients will receive obinutuzumab 1000mg IV (cycle 1: day 1,8,15; Cycle2-6: day1) + venetoclax 400mg/d (preceded by a ramp-up phase) until cycle 9, day 28.~At cycle9:~* if uMRD = Venetoclax 400 mg/d orally until cycle 13.~* if residual disease in the BM or PB = Venetoclax 400 mg/d + Zanubrutinib 160 mg orally twice daily until cycle 21.~then, at cycle 21:~* if uMRD = stop treatment~* if residual disease in the BM or PB = zanubrutinib 160 mg orally twice daily until disease progression"

Trial Locations (8)

Unknown

RECRUITING

Ematologia AOU Careggi, Florence

RECRUITING

Ematologia IRST D.Amadori, Meldola

RECRUITING

Ematologia AO di Perugia, Perugia

RECRUITING

Ematologia Ospedale S.M. delle Croci, Ravenna

RECRUITING

Ematologia Ospedale Infermi, Rimini

RECRUITING

Ematologia Policlinico Gemelli, Roma

RECRUITING

Ematologia Policlinico Umberto I, Roma

RECRUITING

Ematologia AOUS - Policlinico S. M. alle Scotte, Siena

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER