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 (CLL2-BZAG Protocol)

NCT04515238 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	German CLL Study Group
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	42
Start date	2020-10-01
Completion	2026-12

Conditions

• Chronic Lymphoid Leukemia

Interventions

• Bendamustine
• Obinutuzumab
• Zanubrutinib
• Venetoclax

Primary outcomes

• Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by multi-color flow cytometry — At final restaging (RE): 12 weeks after the start of the last induction cycle
  MRD negativity is defined as less than one (1) CLL-cell among 10,000 leukocytes analyzed \[0.01%\]. The MRD negativity rate is defined as the proportion of patients having achieved MRD negativity based on the full analysis set (FAS).

Countries

Germany