Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

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Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Amino Acids

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Zanubrutinib

Prednisone

Rituximab

Vincristine

Lenalidomide

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

six courses of zanubrutinib, rituximab and lenalidomide

six courses of rituximab combined with low-dose CHOP

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.

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.

Weili ZHAO

Pengpeng XU

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

This study will evaluate 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. Subjects will be randomly assigned 1:1 to ZR2 or R-miniCHOP regimen. The stratification will be performed according to international prognostic index (0-2 / 3-5).

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. 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.

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

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: A Multicenter, Prospective, Randomized, Open-label, Controlled Trial

Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Quality of Life will be assessed by EORTC QLQ-C30 (Verison 3.0).

Quality of Life will be assessed by EORTC QLQ-ELD14.

Quality of Life will be assessed by FACT-Lym LymS.

Wuhan Union Hospital, China

Ningbo No. 1 Hospital

National Naval Medical Center

Shanghai Fengxian District Central Hospital

YANCHENG NO.1 PEOPLE'S HOSPITAL

The First Affiliated Hospital of Nanchang University

Affiliated Hospital of Nantong University

Wuxi Branch of Ruijin Hospital

Sir Run Run Shaw Hospital

Northern Jiangsu People's Hospital

The First People's Hospital of Changde City

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Changzhou No.2 People's Hospital

The Affiliated Hospital of Xuzhou Medical University

Huai'an First People's Hospital

Taizhou Hospital

The First People's Hospital of Kunshan

First Affiliated Hospital of Fujian Medical University

Huadong Hospital

Henan Provincial People's Hospital

First Hospital of China Medical University

Shandong Provincial Hospital

HARBIN THE FIRST HOSPITAL

The First Hospital of Jilin University

Hunan Cancer Hospital

Qilu Hospital of Shandong University

THE FIRST AFFILIATED HOSPITAL

The Second Affiliated Hospital of Dalian Medical University

SUZHOU HONGCI HEMATOLOGY HOSPITAL

Ruijin Hospital

First Deputy Director, Hematology Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05179733	Diffuse Large B...	six courses of ... six courses of ...	70 Years -	Ruijin Hospital
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	NCT05179733	Diffuse Large B...	six courses of ... six courses of ...	70 Years -	Ruijin Hospital

Spots Global Cancer Trial Database for six courses of zanubrutinib, rituximab and lenalidomide