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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP-X | Experimental | 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. |
|
| R-CHOP | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab IV infusion will be administered as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to data cut-off (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] |
| Overall survival |
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Inclusion Criteria:
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):
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +862164370045 | 610707 | zwl_trial@163.com |
| Pengpeng Xu | Contact | +862164370045 | 610707 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| C000729508 | orelabrutinib |
| D000077269 | Lenalidomide |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| OTHER |
| The Second Hospital of Anhui Medical University | OTHER |
| Zhongda Hospital | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Tongji Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Zhujiang Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University North District | UNKNOWN |
| Hunan Cancer Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Cancer Hospital Affiliated to Xinjiang Medical University | UNKNOWN |
| The First Affiliated Hospital of Xiamen University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| LanZhou University | OTHER |
| Central South University | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Yunnan Cancer Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Fujian Medical University Union Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Gansu Cancer Hospital | OTHER |
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| RenJi Hospital | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Affiliated Cancer Hospital of Harbin Medical University | UNKNOWN |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Fudan University | OTHER |
| Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College | UNKNOWN |
| Affiliated Hospital of Nantong University | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
| Beijing Tongren Hospital | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The Third Affiliated Hospital of Wenzhou Medical University | OTHER |
| Harbin Institute of Hematology | UNKNOWN |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Affiliated Hospital of Guilin Medical College | UNKNOWN |
| Air Force Military Medical University, China | OTHER |
| Affiliated Zhongshan Hospital of Dalian University | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Peking University Third Hospital | OTHER |
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| Cyclophosphamide | Drug | Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. |
|
| Doxorubicin | Drug | Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm. |
|
| Vincristine | Drug | Vincristine IV infusion will be administered as per the schedule specified in the respective arm. |
|
| Prednisone | Drug | Prednisone PO will be administered as per the schedule specified in the respective arm. |
|
| Orelabrutinib | Drug | Orelabrutinib PO will be administered as per the schedule specified in the respective arm. |
|
| Lenalidomide | Drug | Lenalidomide PO will be administered as per the schedule specified in the respective arm. |
|
| Decitabine | Drug | Decitabine IV infusion will be administered as per the schedule specified in the respective arm. |
|
Overall survival was defined as the time from the date of randomization to the date of death from any cause. |
| Baseline up to data cut-off (up to approximately 2 years) |
| 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. | From enrollment to study completion, a maximum of 4 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D054833 | Isoindoles |
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |