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

NCT07206264 | Not Yet Recruiting Phase 2

• 1 other identifier: ADAPT-MCL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Mantle Cell Lymphoma

Keywords

Lymphoma; Mantle cell lymphoma; Bendamustine; anti-CD20 monoclonal antibody; Orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the time from the initiation of treatment to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. Patients who remain alive and progression-free at the data cutoff date, PFS will be censored at the last tumor assessment date.

  From the date of the initiation of treatment until the date of first documented progression, up to 2 years.

Secondary Outcomes (6)

• Overall response rate (ORR)

  From the initiation of treatment to the end of therapy, up to 2 years.

• Complete response rate (CRR)

  From the initiation of treatment to the end of therapy, up to 2 years.

• Duration of Response (DOR)

  From the first demonstration of response until disease progression/death, up to 2 years.

• Time to response (TTR)

  From the start of therapy to the first documentation of response.

• Overall survival (OS)

  From the date of the initiation of treatment until the date of death, up to 3 years.

Study Arms (1)

Mantle cell lymphoma: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclo

EXPERIMENTAL

Drug: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody

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

Interventions

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

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).

Also known as: BR/OR

Mantle cell lymphoma: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Adequate organ function:
• 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.
• Biochemical: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 times ULN.
• Coagulation function: International normalized ratio (INR) ≤1.5 times ULN;
• Expected survival time ≥12 months;
• Voluntarily sign a written informed consent form before the trial screening.

You may not qualify if:

• 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;
• History of deep vein thrombosis or pulmonary embolism within the past 6 months;
• 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;
• 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;
• Participants with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced lung disease, drug-related lung disease, or other conditions affecting pulmonary function;
• Pregnant women, breastfeeding women, and fertile participants unwilling to use effective contraception;
• Participants requiring continuous use of drugs with strong inhibition or induction effects on cytochrome P450 CYP3A4;
• Other conditions deemed unsuitable for participation in this trial by the investigator.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (5)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Location

Hebei Medical University Tumor Hospital

Shijiazhuang, Hebei, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Shandong Cancer Hospital

Jinan, Shandong, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma

Interventions

Bendamustine Hydrochloride; orelabrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Huilai Zhang

CONTACT

18622221228; zhlwgq@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hulailai Zhang, Tianjin Medical University Cancer Institute and Hospital, Study director

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)