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

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

July 1, 2028

Conditions
Mantle Cell Lymphoma (MCL)
Interventions
DRUG

Orelabrutinib

orelabrutinib 150mg/day PO once daily

DRUG

Rituximab (R)

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

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

Trial Locations (1)

200025

RECRUITING

Ruijin Hospital, Shanghai

All Listed Sponsors
collaborator

Fujian Medical University Union Hospital

OTHER

collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

collaborator

The Third Xiangya Hospital of Central South University

OTHER

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Huadong Hospital

OTHER

lead

Ruijin Hospital

OTHER

NCT07199296 - Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment | Biotech Hunter | Biotech Hunter