A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

NCT05716087 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-01-15

No results posted yet for this study

Summary

This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.

Conditions

  • Mantle Cell Lymphoma (MCL)

Interventions

DRUG

Rocbrutinib

Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Principal Investigators

  • Jun Zhu, MD, PhD · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-12-05
Completion
2026-06-30
FDA Drug
Yes

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 NCT05716087 on ClinicalTrials.gov