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Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)

NCT07719556 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-07-22

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.

Conditions

  • Mantle Cell Lymphoma (MCL)

Interventions

DRUG

Orelabrutinib

Orelabrutinib: 150 mg, d1-d28, C1-C6 (Induction Phase ) ; 150 mg, d1-d28, C7-C24 (Maintenance Phase)

DRUG

Obinutuzumab

Obinutuzumab: 1000 mg/m², on d1, d8, and d15 in C1; and on d1 in C2-C6 (Induction Phase ) ; 1000 mg/m², d1, once every 2 cycles, C7-C24 (Maintenance Phase)

DRUG

Venetoclax

Venetoclax: dose ramp-up in C2 (20 mg → 400 mg); 400 mg on d1-d14 in C3-C6(Induction Phase ) ; 400 mg, d1-d14, C7-C24(Maintenance Phase)

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Yi Xia · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2029-07-01
Completion
2029-07-01

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 NCT07719556 on ClinicalTrials.gov