The Efficacy and Safety of ZR2 Versus R-miniCHOP in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years

Summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of zanubrutinib, rituximab and lenalidomide (ZR2) versus rituximab combined with low-dose CHOP (R-miniCHOP) in the treatment of unfit or frail de novo diffuse large B-cell lymphoma patients aged older than or equal to 70 years

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

DRUG

six courses of zanubrutinib, rituximab and lenalidomide

Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day 1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously, every 21 days.

DRUG

six courses of rituximab combined with low-dose CHOP

Patients in R-miniCHOP group will receive rituximab 375 mg/m² on day 1, cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and vincristine 1 mg on day 2, and prednisone 40 mg/m² on days 2-6, every 21 days.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• National Naval Medical Center

  collaborator FED

• Shanghai Fengxian District Central Hospital

  collaborator OTHER

• YANCHENG NO.1 PEOPLE'S HOSPITAL

  collaborator UNKNOWN

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Changzhou No.2 People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• The First People's Hospital of Kunshan

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Huadong Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• HARBIN THE FIRST HOSPITAL

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• THE FIRST AFFILIATED HOSPITAL

  collaborator UNKNOWN

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• SUZHOU HONGCI HEMATOLOGY HOSPITAL

  collaborator UNKNOWN

• Ruijin Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-02

Primary Completion

2025-12-25

Completion

2025-12-25

Countries

• China

Study Locations