Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Base… (NCT07206264) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment
China45 participantsStarted 2025-10
Plain-language summary
This is a single-arm, multi-center, prospective, phase II study. The primary objective is to assess the efficacy and safety of bendamustine/orelabrutinib combined with an anti-CD20 monoclonal antibody in treatment-naïve patients with mantle cell lymphoma.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Gender not limited, aged ≥65 years, or aged ≥60 years but \<65 years and unsuitable or unwilling to undergo stem cell transplantation due to the following reasons:
. Creatinine clearance rate \>30 mL/min, but \<70 mL/min;
. Presence of other comorbidities that contraindicate high-intensity induction chemotherapy;
. High-risk patients who are expected to fail stem cell mobilization and collection (such as those with bone marrow infiltration, diabetes, thrombocytopenia). Patients who are unwilling to receive autologous stem cell transplantation, considering potential complications post-transplantation (such as prolonged bleeding, immunodeficiency, hemorrhage, severe infections), and relapse.
. Histologically confirmed mantle cell lymphoma at stages II-IV;
. Patients who have not received prior treatment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From the date of the initiation of treatment until the date of first documented progression, up to 2 years.
Trial details
NCT IDNCT07206264
SponsorTianjin Medical University Cancer Institute and Hospital
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
. Adequate organ function:
Exclusion criteria
. Progression to higher-grade disease or central nervous system involvement;
. Uncontrolled or significant cardiovascular diseases:
. Within 6 months prior to the first administration of the study drug, there was New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or a need for treatment of arrhythmia at the time of screening, with left ventricular ejection fraction (LVEF) \< 50%;
. Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and unclassified cardiomyopathy);
. A history of clinically significant QTc interval prolongation, or a QTc interval \>470 ms for females or \>450 ms for males during the screening period;
. Participants with symptomatic or medication-requiring coronary artery disease;
. Participants with uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite adequate therapy with three antihypertensive agents (including a diuretic) for at least one month, or requiring four or more antihypertensive agents to achieve control.
. Participants with active bleeding within 2 months prior to screening, those currently on anticoagulant therapy, or those deemed by the investigator to have a significant risk of bleeding;