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

PHASE3RecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

December 25, 2025

Study Completion Date

December 25, 2025

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.

Trial Locations (1)

200020

RECRUITING

Ruijin Hospital, Shanghai

All Listed Sponsors
collaborator

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

OTHER

collaborator

Ningbo No. 1 Hospital

OTHER

collaborator

National Naval Medical Center

FED

collaborator

Shanghai Fengxian District Central Hospital

OTHER

collaborator

YANCHENG NO.1 PEOPLE'S HOSPITAL

UNKNOWN

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

collaborator

Affiliated Hospital of Nantong University

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

collaborator

Northern Jiangsu People's Hospital

OTHER

collaborator

The First People's Hospital of Changde City

OTHER

collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

collaborator

Changzhou No.2 People's Hospital

OTHER

collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

collaborator

Huai'an First People's Hospital

OTHER

collaborator

Taizhou Hospital

OTHER

collaborator

The First People's Hospital of Kunshan

OTHER

collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

collaborator

Huadong Hospital

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

First Hospital of China Medical University

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

HARBIN THE FIRST HOSPITAL

UNKNOWN

collaborator

The First Hospital of Jilin University

OTHER

collaborator

Hunan Cancer Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

THE FIRST AFFILIATED HOSPITAL

UNKNOWN

collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

collaborator

SUZHOU HONGCI HEMATOLOGY HOSPITAL

UNKNOWN

lead

Ruijin Hospital

OTHER

NCT05179733 - 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 | Biotech Hunter | Biotech Hunter