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Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL

NCT04515238 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-06-10

No results posted yet for this study

Summary

CLL2-BZAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by obinutuzumab (GA101), zanubrutinib (BGB-3111) and venetoclax (ABT-199) in patients with relapsed/refractory CLL.

Conditions

  • Chronic Lymphoid Leukemia

Interventions

DRUG

Bendamustine

Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.

BIOLOGICAL

Obinutuzumab

Induction: Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg i.v.; Cycle 2 - 6: 1000 mg, d1 i.v. Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v.

BIOLOGICAL

Zanubrutinib

Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 160mg p.o. Maintenance: Cycle 1 - 8: d1-84: 2 x 160mg p.o

BIOLOGICAL

Venetoclax

Induction: Cycles 1 + 2: --; Cycle 3: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg p.o.; Cycle 4 - 6: d1-28: 400 mg p.o. Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o.

Sponsors & Collaborators

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Paula Cramer, Dr. med. · German CLL Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT04515238 on ClinicalTrials.gov