Diffuse Large B Cell Lymphoma
Conditions
Brief 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
Interventions
DRUGRituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
DRUGCyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUGDoxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUGVincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUGPrednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
DRUGOrelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
DRUGLenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DRUGDecitabine
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Sponsors
West China Hospital, Sichuan
Qilu Hospital of Shandong University
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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, Shanghai Jiao Tong University School of Medicine
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
RenJi Hospital
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
Affiliated Hospital of Nantong University
Yunnan First People's Hospital
Shanxi Province Cancer Hospital
Fifth Affiliated Hospital of Guangzhou Medical University
Beijing Tongren Hospital
First Affiliated Hospital of Harbin Medical University
The Third Affiliated Hospital of Wenzhou Medical University
Harbin Institute of Hematology
The First Affiliated Hospital of Guangzhou Medical University
Affiliated Hospital of Guilin Medical College
Air Force Military Medical University, China
Affiliated Zhongshan Hospital of Dalian University
Yantai Yuhuangding Hospital
The First Affiliated Hospital of Zhengzhou University
Peking University Third Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement) * Availability of archival or freshly collected tumor tissue before study enrolment * International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 6 months * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
Exclusion criteria
* Previous chemotherapy. * Previous stem cell transplantation. * History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Patients with central nervous system (CNS) lymphoma * Primary mediastinal large B-cell lymphoma * Left ventricular ejection fraction\<50% * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): 1. Neutrophils\<1.5×10\^9/L 2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) 3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. 4. Creatinine is 1.5 times higher than the ULN. * HIV-infected patients * Positive test results for chronic hepatitis B and hepatitis C infection * Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol * Pregnant or lactation * Require treatment with strong/moderate CYP3A inhibitors or inducers. * Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction * Other medical conditions determined by the researchers that may affect the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline up to data cut-off (up to approximately 2 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Overall survival | Baseline up to data cut-off (up to approximately 2 years) | Overall survival was defined as the time from the date of randomization to the date of death from any cause. |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | From enrollment to study completion, a maximum of 4 years | 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. |
Countries
China
Contacts
Primary ContactWeili Zhao
Backup ContactPengpeng Xu
Outcome results
None listed