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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bendamustine — DRUG
  Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.
• Obinutuzumab — BIOLOGICAL
  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.
• Zanubrutinib — BIOLOGICAL
  Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 160mg p.o. Maintenance: Cycle 1 - 8: d1-84: 2 x 160mg p.o
• Venetoclax — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2020

Status verified

Jun 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

42 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BZAG
  Debulking: 2 debulking cycles (q 28d) of bendamustine will be administered unless the patient has a contraindication or a debulking is not clinically indicated Induction: 6 cycles (q 28d) of Obinutuzumab + Zanubrutinib + Venetoclax Maintenance: max. 8 cycles (q 84d) of Obinutuzumab + Zanubrutinib + Venetoclax Maintenance treatment will be continued until (whichever occurs first): * 12 weeks (approx. 3 months) after confirmation of achievement of a CR/CRi and MRD negativity * maintenance cycle 8 * progression of CLL or start of a subsequent therapy unacceptable toxicity

Primary Outcome Measure

Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by multi-color flow cytometry [ Time Frame: At final restaging (RE): 12 weeks after the start of the last induction cycle ]