Genotype-guided Treatment in DLBCL

Summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Orelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

DRUG

Decitabine

Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

Sponsors & Collaborators

• West China Hospital, Sichuan

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

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

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University North District

  collaborator UNKNOWN

• Hunan Cancer Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

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

  collaborator OTHER

• Cancer Hospital Affiliated to Xinjiang Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Central South University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Fujian Medical University Union Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Gansu Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Affiliated Cancer Hospital of Harbin Medical University

  collaborator UNKNOWN

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College

  collaborator UNKNOWN

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Yunnan First People's Hospital

  collaborator UNKNOWN

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Fifth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Harbin Institute of Hematology

  collaborator UNKNOWN

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Affiliated Hospital of Guilin Medical College

  collaborator UNKNOWN

• Air Force Military Medical University, China

  collaborator OTHER

• Affiliated Zhongshan Hospital of Dalian University

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Ruijin Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2026-06-01

Completion

2026-06-01

Countries

• China

Study Locations