Actively Recruiting
A Prospective Multicenter Study of Orelabrutinib Combined With Zebetuzumab and Lenalidomide or Bendamustine Combined With Rituximab for Newly Diagnosed Marginal Zone Lymphoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-10-06
169
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two treatment combinations for adults newly diagnosed with marginal zone lymphoma (MZL). This phase 2, open-label, multicenter study compares orelabrutinib combined with zebetuzumab and lenalidomide against bendamustine combined with rituximab. The goal is to understand how well these treatments work and their safety in treating this type of lymphoma. Participants will receive one of two treatment plans. The first group undergoes an induction phase of six 28-day cycles with orelabrutinib, zebetuzumab, and lenalidomide, followed by a maintenance phase of 24 cycles with orelabrutinib if they respond well. The second group receives six 28-day cycles of bendamustine and rituximab. Treatment dosing and schedule are carefully monitored throughout the study. During the study, participants will have regular assessments including response evaluations at multiple cycle days, quality of life questionnaires, and monitoring of side effects. Researchers will track progression-free survival up to 66 months, overall survival, and other key outcomes. Safety will be observed from screening through three years after maintenance therapy ends. Participants may be involved for several years in total to allow detailed evaluation of treatment effects and safety.
CONDITIONS
Brief Title
Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Histopathologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one measurable lesion
- Indication for treatment based on disease stage and symptoms, including specific clinical criteria for gastric and non-gastric forms
- No prior systemic treatment; may include relapsed or progressed MZL after local therapy
- ECOG performance status of 0 to 2
- Adequate organ function meeting blood count, liver, kidney, and coagulation criteria
- Expected survival time of at least 12 months
- Voluntary signed informed consent before screening
You will not qualify if you...
- Other malignancies within the past 5 years except certain cured skin and cervical cancers
- Lymphoma involving the central nervous system or higher-grade transformation
- Uncontrolled or significant cardiovascular diseases including severe heart failure, recent heart attack, treatable arrhythmias, primary cardiomyopathies, QTc prolongation, symptomatic coronary disease, or uncontrolled hypertension
- Active bleeding or current anticoagulant use
- History of deep vein thrombosis or pulmonary embolism in past 6 months
- Recent major or minor surgery within specified timeframes
- Active infection or uncontrolled hepatitis B, hepatitis C, HIV/AIDS, or other serious infections
- Severe lung function impairment
- Pregnant or lactating women and those unwilling to use contraception
- Use of medications affecting cytochrome P450 CYP3A
- Other conditions deemed unsuitable by the investigator
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 - Induction phase: 6 cycles of 28 days each; Maintenance phase: up to 24 cycles of 28 days each for some participants
Participants undergo induction treatment with cycles lasting 28 days each. Depending on the assigned group, treatment includes either a combination of Orelabrutinib, Zebetuzumab, and Lenalidomide for 6 cycles or Bendamustine combined with Rituximab for 6 cycles. Participants in the Orelabrutinib group who achieve remission may continue with maintenance therapy of Orelabrutinib for up to 24 additional cycles.
Visits on Day 1 of each 28-day cycle during induction and maintenance phases
Duration - Up to 3 years
Participants are monitored for safety and disease progression for up to 3 years after the end of maintenance therapy or treatment.
Periodic visits during follow-up as scheduled by the study team
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jianyong Li, PhD, MD
H
Huayuan Zhu, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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