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Recruiting NCT06363994

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Phase III Interventional Mantle Cell Lymphoma

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 Injection, Rituximab, Orelabrutinib Placebo.
Who it may be relevant to
Registry conditions: Mantle Cell Lymphoma. Basic parameters: from 60 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 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

Overview

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Interventions

  • Drug Orelabrutinib
    Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
  • Drug Bendamustine Injection
    Eligible patients will receive Bendamustine by injection as per the protocol
  • Drug Rituximab
    Eligible patients will receive Rituximab by injection as per the protocol
  • Drug Orelabrutinib Placebo
    Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 28 days]
  • Progression-free Survival (PFS) for Arm A vs. Arm B [Time frame: Approximately 7 years]

Eligibility criteria

Inclusion criteria

  • 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).
  • ECOG PS score of 0 to 2.

Exclusion criteria

  • 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.
  • Known central nervous system lymphoma.

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
Quadruple blind
Primary purpose
Treatment

Study locations

China · 39 centers
  • Beijing Cancer Hospital — Beijing
  • Peking University Third Hospital — Beijing
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • First Hospital of Jilin University — Changchun
  • Hunan Cancer Hospital — Changsha
  • The First People's Hospital of Changzhou — Changzhou
  • Sichuan Provincial People's Hospital — Chengdu
  • West China Hospital of Sichuan University — Chengdu
  • … and 31 more centers

Identifiers

NCT: NCT06363994 · ICP-CL-00128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗