Back to resultsGenotype-guided Treatment in DLBCL
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Orelabrutinib
Lenalidomide
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma
Eligibility Criteria
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):
- Neutrophils<1.5×10^9/L
- Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
- 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.
- 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
Sites / Locations
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
R-CHOP-X
R-CHOP
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression-free survival
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 Outcome Measures
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Overall survival
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
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.
Full Information
NCT ID
NCT05351346
First Posted
April 24, 2022
Last Updated
March 22, 2023
Sponsor
Ruijin Hospital
Collaborators
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, 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, Ruian People's Hospital, Harbin Institute of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guilin Medical College, Air Force Military Medical University, China, The Affiliated Zhongshan Hospital of Dalian University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05351346
Brief Title
Genotype-guided Treatment in DLBCL
Official Title
A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
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, 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, Ruian People's Hospital, Harbin Institute of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guilin Medical College, Air Force Military Medical University, China, The Affiliated Zhongshan Hospital of Dalian University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CHOP-X
Arm Type
Experimental
Arm Description
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.
Arm Title
R-CHOP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone PO will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib
Intervention Description
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time Frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Title
Overall survival
Description
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Description
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.
Time Frame
From enrollment to study completion, a maximum of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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):
Neutrophils<1.5×10^9/L
Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao
Phone
+862164370045
Ext
610707
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu
Phone
+862164370045
Ext
610707
Email
pengpeng_xu@126.com
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, M.D. and Ph.D
Phone
13512112076
Email
zhao.weili@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Genotype-guided Treatment in DLBCL
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