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Clinical Trials in China / NCT07206264
Starting soon Phase 2

Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment

NCT07206264 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 2
Started
2025-10
Last updated
2025-10-03

Condition(s) studied

Mantle Cell Lymphoma

Investigational drug(s) / intervention(s)

Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody

Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody: Induction phase (cycle 1-6): Bendamustine (90 mg/m², day 1-2) +anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 1-4. Patients who achieve CR and MRD negative continue to receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 5-6; MRD positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0). Maintenance phase (cycle 7-24): Patients who achieve CR and are MRD negative at cycle 4 receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0); MRD-positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0).

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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: 1. Creatinine clearance rate \>30 mL/min, but \<70 mL/min; 2. Presence of other comorbidities that contraindicate high-intensity induction chemotherapy; 3. 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. 2. Histologically confirmed mantle cell lymphoma at stages II-IV; 3. Patients who have not received prior treatment; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Adequate organ function: 1. Hematological: Absolute neutrophil count ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75 g/L. If accompanied by bone marrow involvement: Absolute neutrophil count ≥1.0×109/L, platelets ≥50×109/L, hemoglobin ≥50 g/L. 2. Biochemical: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 times ULN. 6. Coagulation function: International normalized ratio (INR) ≤1.5 times ULN; 7. Expected survival time ≥12 months; 8. Voluntarily sign a written informed consent form before the trial screening. Exclusion Criteria: 1. Progression to higher-grade disease or central nervous system involvement; 2. Uncontrolled or significant cardiovascular diseases: 1. 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%; 2. Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and unclassified cardiomyopathy); 3. 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; 4. Participants with symptomatic or medication-requiring coronary artery disease; 5. 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. 3. 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; 4. History of deep vein thrombosis or pulmonary embolism within the past 6 months; 5. Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery is defined as any surgical procedure requiring general anesthesia; diagnostic endoscopy is not considered major surgery; 6. Active infection or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with detectable HBV DNA), hepatitis C virus (HCV) antibody positive, HIV/AIDS, or other severe infectious diseases; 7. Participants with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced lung disease, drug-related lung disease, or other conditions affecting pulmonary function; 8. Pregnant women, breastfeeding women, and fertile participants unwilling to use effective contraception; 9. Participants requiring continuous use of drugs with strong inhibition or induction effects on cytochrome P450 CYP3A4; 10. Other conditions deemed unsuitable for participation in this trial by the investigator.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Fujian Provincial Cancer Hospital Fuzhou Fujian
Hebei Medical University Tumor Hospital Shijiazhuang Hebei
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Shandong Cancer Hospital Jinan Shandong
Tianjin Medical University Cancer Institute and Hospital Tianjin China

More Tianjin Medical University Cancer Institute and Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206264 on ClinicalTrials.gov ↗ ← All trials in China