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NOT YET RECRUITING
NCT07899398
PHASE2

A Trial to Evaluate the Efficacy and Safety of a Fitness-adapted Thera-py Approach With Either Continuous Zanubrutinib Monotherapy or Time-limited Zanubrutinib + Sonrotoclax in Older and/or Frail Patients With Treatment-naïve CLL

Sponsor: German CLL Study Group

View on ClinicalTrials.gov

Summary

The CLL-Frail2 trial will be a prospective, open-label, multicentre phase-II-trial to evaluate the efficacy and safety of a fitness-adapted therapy approach with either con-tinuous zanubrutinib (BGB-3111) monotherapy or time-limited zanubrutinib + sonrotoclax (BGB-11417) in older (aged ≥80 years) and/or frail patients with treatment-naïve CLL. The primary objective of the study is to evaluate the efficacy and safety of fitness-adapted therapy in older (aged ≥80 years) and/or frail patients with treatment-naïve CLL.

Official title: A Prospective, Open-label, Multicentre Phase-II-trial to Evaluate the Efficacy and Safety of a Fitness-adapted Therapy Approach With Either Continuous Zanubrutinib (BGB-3111) Monotherapy or Time-limited Zanubrutinib + Sonrotoclax (BGB-11417) in Older (Aged ≥80 Years) and/or Frail Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-12-01

Completion Date

2031-01-01

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Zanubrutinib

Zanubrutinib maintainance + run-in

DRUG

Sonrotoclax

12 cycles sonrotoclax infusion