The Efficacy and Safety of ZR2 Versus R-miniCHOP in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years
NCT ID: NCT05179733
Last Updated: 2023-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
280 participants
INTERVENTIONAL
2022-03-02
2025-12-25
Brief Summary
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Detailed Description
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Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day 1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously, every 21 days. Patients in R-miniCHOP group will receive rituximab 375 mg/m² on day 1, cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and vincristine 1 mg on day 2, and prednisone 40 mg/m² on days 2-6, every 21 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ZR2
six courses of zanubrutinib, rituximab and lenalidomide
six courses of zanubrutinib, rituximab and lenalidomide
Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day 1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously, every 21 days.
R-miniCHOP
six courses of rituximab combined with low-dose CHOP
six courses of rituximab combined with low-dose CHOP
Patients in R-miniCHOP group will receive rituximab 375 mg/m² on day 1, cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and vincristine 1 mg on day 2, and prednisone 40 mg/m² on days 2-6, every 21 days.
Interventions
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six courses of zanubrutinib, rituximab and lenalidomide
Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day 1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously, every 21 days.
six courses of rituximab combined with low-dose CHOP
Patients in R-miniCHOP group will receive rituximab 375 mg/m² on day 1, cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and vincristine 1 mg on day 2, and prednisone 40 mg/m² on days 2-6, every 21 days.
Eligibility Criteria
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Inclusion Criteria
* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
* Eastern Cooperative Oncology Group performance status 0-3
* Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail
* International normalized ratio and activated partial thromboplastin time are both 1.5 times lower than the upper limits of normal (ULN).
* At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
* Life expectancy of at least 3 months determined by researchers
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
* Anti-lymphoma drugs have not been used before (except glucocorticoids).
Exclusion Criteria
* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
1. Neutrophils\<1.5×10\^9/L
2. Platelets\<80×10\^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 or eGFR is lower than 40ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation).
* HIV-infected patients
* Left ventricular ejection fraction\<50%
* Patients with HbsAg positive are required to have HBV DNA\<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\<1.0×10\^3 IU/ml is required before entering the group.
* Other anti-tumor treatments (lymphoma or other types of tumors) are currently in progress.
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* Require treatment with strong/moderate CYP3A inhibitors or inducers.
* History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
* 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
70 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Ningbo No. 1 Hospital
OTHER
National Naval Medical Center
FED
Shanghai Fengxian District Central Hospital
OTHER
YANCHENG NO.1 PEOPLE'S HOSPITAL
UNKNOWN
The First Affiliated Hospital of Nanchang University
OTHER
Affiliated Hospital of Nantong University
OTHER
Sir Run Run Shaw Hospital
OTHER
Northern Jiangsu People's Hospital
OTHER
The First People's Hospital of Changde City
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Changzhou No.2 People's Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Huai'an First People's Hospital
OTHER
Taizhou Hospital
OTHER
The First People's Hospital of Kunshan
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Huadong Hospital
OTHER
Henan Provincial People's Hospital
OTHER
First Hospital of China Medical University
OTHER
Shandong Provincial Hospital
OTHER_GOV
HARBIN THE FIRST HOSPITAL
UNKNOWN
The First Hospital of Jilin University
OTHER
Hunan Cancer Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
THE FIRST AFFILIATED HOSPITAL
UNKNOWN
The Second Affiliated Hospital of Dalian Medical University
OTHER
SUZHOU HONGCI HEMATOLOGY HOSPITAL
UNKNOWN
Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director, Hematology Department
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NHL-014
Identifier Type: -
Identifier Source: org_study_id
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