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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

NCT05478512 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2026-05-31
Completion
2027-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478512 on ClinicalTrials.gov