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Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

NCT06496308 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Mantle Cell Lymphoma (MCL)

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.

Sponsors & Collaborators

  • Third Xiangya Hospital of Central South University

    collaborator UNKNOWN

  • Anhui Provincial Cancer Hospital

    collaborator OTHER

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • Huadong Hospital Affiliated with Fudan University, Shanghai

    collaborator UNKNOWN

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Jiangxi Provincial Cancer Hospital

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2027-07-10
Completion
2027-07-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06496308 on ClinicalTrials.gov