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

NCT06363994 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2024-12-27

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • InnoCare Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2031-06-25
Completion
2032-06-25
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06363994 on ClinicalTrials.gov