Recruiting

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

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What is being tested

Orelabrutinib

+ Bendamustine Injection

+ Rituximab

Drug
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 60 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorInnoCare Pharma Inc.
Study ContactAlexia Lu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 29, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a new treatment combination for patients diagnosed with mantle cell lymphoma (MCL) who have not received any prior treatment. MCL is a type of cancer that affects the lymphatic system, and finding effective treatments for it is crucial. The study explores whether combining a drug called Orelabrutinib with existing treatments, bendamustine and rituximab, offers better outcomes compared to using just bendamustine and rituximab. This research is important as it aims to improve treatment options and outcomes for those facing this challenging cancer. Participants in this study will be randomly assigned to receive either the combination of Orelabrutinib, bendamustine, and rituximab, or just bendamustine and rituximab. The treatment is administered through injections and oral medication, depending on the specific drug. Throughout the study, researchers will closely monitor participants to assess how well the cancer responds to the treatment and to identify any side effects. The goal is to determine if adding Orelabrutinib to the treatment regimen enhances its effectiveness and maintains safety, potentially offering patients a more effective option for managing their MCL.

Official TitleA Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
NCT06363994
Principal SponsorInnoCare Pharma Inc.
Study ContactAlexia Lu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

476 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, Mantle-Cell

Criteria

5 inclusion criteria required to participate
Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
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5 exclusion criteria prevent from participating
Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Recruiting

Beijing Cancer Hospital

Beijing, ChinaOpen Beijing Cancer Hospital in Google Maps
Recruiting

Peking University Third Hospital

Beijing, China
Recruiting

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China
Recruiting

Hunan Cancer Hospital

Changsha, China
Recruiting
39 Study Centers