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Recruiting NCT06496308

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

Phase III Interventional Mantle Cell Lymphoma (MCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orelabrutinib, Bendamustine, Rituximab, Venetoclax.
Who it may be relevant to
Registry conditions: Mantle Cell Lymphoma (MCL). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)

Overview

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.

Interventions

  • Drug Orelabrutinib
    Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
  • Drug Bendamustine
    Bendamustine IV will be administered as per the schedule specified in the respective arm.
  • Drug Rituximab
    Rituximab IV will be administered as per the schedule specified in the respective arm.
  • Drug Venetoclax
    Venetoclax PO will be administered as per the schedule specified in the respective arm.

Primary outcome measures

  • Complete response rate [Time frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]]
Secondary outcome measures (3)
  • Overall Response Rate [Time frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]]
  • Progression-free survival [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
  • Overall survival [Time frame: Baseline up to data cut-off (up to approximately 2 years)]

Eligibility criteria

Inclusion criteria

  • Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
  • Age > 18 years of age, both genders are eligible.
  • Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
  • At least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 > 50%, TP53 abnormality, blastic or pleomorphic variation.
  • Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.
  • Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet count ≥75×10\^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.
  • The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.
  • Willing and able to participate in all required assessments and procedures of the study protocol.

Exclusion criteria

  • Patients who have previously received treatment with BTK inhibitors.
  • Patients with severe complications or serious infections.
  • Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
  • Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
  • HIV-infected individuals.
  • Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
  • Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital — Shanghai

Identifiers

NCT: NCT06496308 · ORDER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗