Actively Recruiting
Orelabrutinib Combined With Rituximab Versus R-CVP in Untreated Marginal Zone Lymphoma A Randomized, Open-Label Phase II Trial
Led by Fei Li · Updated on 2025-06-17
90
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of combining orelabrutinib with rituximab compared to the R-CVP regimen in patients with previously untreated marginal zone lymphoma (MZL). This randomized, open-label, multicenter, phase II clinical trial focuses on patients with advanced-stage MZL who require treatment. The study aims to explore a chemotherapy-free option using orelabrutinib, a second-generation BTK inhibitor that has shown promise in relapsed or refractory MZL, followed by maintenance therapy. Participants are assigned to one of two treatment groups. One group receives oral orelabrutinib 150mg once daily for 24 cycles (each cycle lasting 4 weeks) combined with intravenous rituximab 375mg/m2 on day 1 of each of the first 6 cycles. The other group receives the R-CVP regimen, consisting of intravenous rituximab, cyclophosphamide, vincristine, and oral prednisone over 8 cycles (each cycle lasting 3 weeks), followed by rituximab maintenance therapy for up to two years or until intolerable toxicity. Throughout the study, participants will undergo regular assessments including imaging scans such as enhanced CT or MRI to measure lesions, laboratory tests, and safety monitoring for up to three years. Researchers will track response rates, progression-free survival, and safety parameters. The primary outcome is the complete response rate assessed up to two years. Participants will be monitored closely to evaluate treatment effects and ensure compliance with study procedures during this period.
CONDITIONS
Brief Title
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status level 0 to 2
- Life expectancy of at least 12 weeks
- Confirmed CD20-positive marginal zone lymphoma including splenic, nodal, and extranodal subtypes
- Measurable lesions detected by enhanced CT or MRI
- Indication for treatment according to NCCN guidelines with no prior systemic treatment for MZL
- Normal function of major organs
- Women of childbearing age must use reliable contraception and have a negative pregnancy test within 7 days before enrollment; men must agree to use contraception or have surgical sterilization during the trial and for 8 weeks after last treatment
- Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up
You will not qualify if you...
- Central nervous system involvement
- History or current untreated malignant tumors except cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer
- Cardiovascular diseases including Grade II or higher myocardial ischemia or infarction, poorly controlled arrhythmias, Class III to IV heart failure, or left ventricular ejection fraction below 50%
- Coagulation abnormalities or use of thrombolytic or anticoagulant therapy
- Arterial or venous thrombotic events within 12 months prior to enrollment
- Known hereditary or acquired bleeding or thrombotic disorders
- Major surgery, severe trauma, fractures, or ulcers within 4 weeks prior to enrollment
- Conditions affecting absorption of oral medications such as inability to swallow or intestinal obstruction
- Active infections requiring antimicrobial treatment except chronic hepatitis B antiviral treatment
- Active hepatitis B or C infection as defined by viral load or antibody status
- History of substance abuse or mental disorders preventing participation
- Participation in other anticancer drug trials within 4 weeks prior to enrollment
- Recent use of potent CYP3A4 inhibitors or inducers within specified time frames
- Pregnant or breastfeeding women or those unwilling to use contraception
- Other conditions judged by the investigator to affect study conduct or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks for orelabrutinib combination and up to 24 weeks for R-CVP treatment cycles
Participants receive either orelabrutinib combined with rituximab followed by maintenance orelabrutinib, or the R-CVP regimen including rituximab, cyclophosphamide, vincristine, and prednisone.
Orelabrutinib arm: 6 cycles of rituximab every 4 weeks with daily orelabrutinib for 24 cycles; R-CVP arm: 8 cycles every 3 weeks
Duration - Up to 2 years
Participants are monitored for treatment response and safety, including maintenance therapy with rituximab monotherapy for up to two years or until intolerable toxicity.
Visits scheduled according to maintenance therapy and monitoring up to two years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
Research Team
Y
Yulan Zhou Doctor, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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