Trials / Recruiting
RecruitingNCT07377578
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocbrutinib | Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity |
| DRUG | Ibrutinib | Ibrutinib, 560 mg once daily orally and continuously |
| DRUG | Acalabrutinib | Acalabrutinib, 100 mg twice daily orally and continuously |
| DRUG | Zanubrutinib | Zanubrutinib, 160 mg twice daily orally and continuously |
| DRUG | Orelabrutinib | Orelabrutinib, 150 mg once daily orally and continuously |
Timeline
- Start date
- 2026-02-05
- Primary completion
- 2031-05-30
- Completion
- 2033-01-30
- First posted
- 2026-01-30
- Last updated
- 2026-02-06
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07377578. Inclusion in this directory is not an endorsement.