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Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment

NCT07199296 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-09-30

No results posted yet for this study

Summary

This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal 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

Rituximab (R)

rituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle

DRUG

Orelabrutinib

orelabrutinib 150mg/day PO once daily

DRUG

BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)

the reference doses are as follows (each center may adjust them as appropriate based on actual conditions): carmustine 300mg/m² IV d-1; etoposide 200mg/m² IV d-6-(-3); cytarabine 200mg/m² IV d-6-(-3); melphalan 140mg/m² IV d-2.

DRUG

orelabrutinib maintenance

orelabrutinib 150mg/day PO once daily

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-07-01
Completion
2028-07-01

Countries

  • China

Study Locations

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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 NCT07199296 on ClinicalTrials.gov