Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Decitabine

Prednisone

Rituximab

Vincristine

Lenalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle.

Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles.

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

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

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

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

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

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

Orelabrutinib

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

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

Weili Zhao

Pengpeng Xu

Weili Zhao, M.D. and Ph.D

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

Genotype-guided Treatment in DLBCL

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

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.

West China Hospital, Sichuan

Qilu Hospital of Shandong University

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Wuhan Union Hospital, China

The Second Hospital of Anhui Medical University

Zhongda Hospital

The First Affiliated Hospital of Soochow University

China-Japan Friendship Hospital

Tongji Hospital

Beijing Hospital

The Second Affiliated Hospital of Dalian Medical University

Zhujiang Hospital

The First Affiliated Hospital of Anhui Medical University North District

Hunan Cancer Hospital

Liaoning Cancer Hospital & Institute

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Cancer Hospital Affiliated to Xinjiang Medical University

The First Affiliated Hospital of Xiamen University

The First Affiliated Hospital of Nanchang University

LanZhou University

Central South University

The Affiliated Hospital of Xuzhou Medical University

Yunnan Cancer Hospital

Henan Cancer Hospital

Fujian Medical University Union Hospital

The First Hospital of Jilin University

The First Affiliated Hospital of Anhui Medical University

Gansu Cancer Hospital

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

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Second Affiliated Hospital of Xi'an Jiaotong University

First Affiliated Hospital Xi'an Jiaotong University

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shandong Cancer Hospital and Institute

Affiliated Cancer Hospital of Harbin Medical University

First Affiliated Hospital of Chongqing Medical University

Fudan University

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

Spots Global Cancer Trial Database for Genotype-guided Treatment in DLBCL

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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