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
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Drug: six courses of zanubrutinib, rituximab and lenalidomideDrug: six courses of rituximab combined with low-dose CHOP
- Registration Number
- NCT05179733
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of zanubrutinib, rituximab and lenalidomide (ZR2) versus rituximab combined with low-dose CHOP (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
- Detailed Description
This study will evaluate 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. Subjects will be randomly assigned 1:1 to ZR2 or R-miniCHOP regimen. The stratification will be performed according to international prognostic index (0-2 / 3-5).
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZR2 six courses of zanubrutinib, rituximab and lenalidomide six courses of zanubrutinib, rituximab and lenalidomide R-miniCHOP six courses of rituximab combined with low-dose CHOP six courses of rituximab combined with low-dose CHOP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Complete response rate At the end of Cycle 6 (each cycle is 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.
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-ELD14 (Elderly Module) Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion Quality of Life will be assessed by EORTC QLQ-ELD14.
Percentage of Participants Achieving Meaningful Improvement in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion Quality of Life will be assessed by EORTC QLQ-C30 (Verison 3.0).
Percentage of Participants Achieving Meaningful Improvement in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS) Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion Quality of Life will be assessed by FACT-Lym LymS.
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China