A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06554600
Phase
PHASE2
Status
Recruiting
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Conditions

  • Refractory or Relapsed Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    160mg bid PO（d0-d20）
  • Polatuzumab Vedotin — DRUG
    Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin on Day 2 of each cycle.
  • Bendamustine — DRUG
    Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 70 mg/m2 Bendamustine on Days 2 and 3 of each cycle.
  • Rituximab — DRUG
    Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab on Day 1 of each cycle.

Study Details

This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.

Key Dates

Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pola-ZBR treatment
    Relapsed/refractory DLBCL were treated with 4 courses of Pola-ZBR regimen. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year.

Primary Outcome Measure

Objective Response rate（ORR） [ Time Frame: Up to 12 weeks ]

Central Contacts