Trials / Active Not Recruiting
Active Not RecruitingNCT05716087
A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma
An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-02-21
- Primary completion
- 2024-12-05
- Completion
- 2026-06-30
- First posted
- 2023-02-08
- Last updated
- 2026-01-15
Locations
43 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05716087. Inclusion in this directory is not an endorsement.