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: A Multicenter, Prospective, Randomized, Open-label, Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- six courses of zanubrutinib, rituximab and lenalidomide
- Conditions
- Diffuse Large B-Cell Lymphoma
- Sponsor
- Ruijin Hospital
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ZR2
six courses of zanubrutinib, rituximab and lenalidomide
Intervention: six courses of zanubrutinib, rituximab and lenalidomide
R-miniCHOP
six courses of rituximab combined with low-dose CHOP
Intervention: six courses of rituximab combined with low-dose CHOP
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 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 Outcomes
- Overall survival(Baseline up to data cut-off (up to approximately 2 years))
- Complete response rate(At the end of Cycle 6 (each cycle is 21 days))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(From enrollment to study completion, a maximum of 4 years)
- 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)
- 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)
- 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)