NCT07377578RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- 5 Feb 2026
- Primary completion date
- 30 May 2031
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT07377578
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 394
- From 5 Feb 2026 to the primary completion date, 30 May 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any BTK-targeted therapy (except for intolerance).
- History of major cardiovascular events within 6 months prior to randomization.
- Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.
Other illness
- Hypersensitivity to Rocbrutinib or any study drug in the control group.
- History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.
- Presence of any severe and/or uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.
- Uncontrolled active bacterial, fungal, or viral systemic infection, or active tuberculosis infection.
Other
- Central nervous system (CNS) involvement by lymphoma.
Who the study is looking for
- Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.
- Have at least one measurable lesion according to the Lugano Response Criteria 2014.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.
- Toxicities or complications from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
- All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating.
- Subject voluntarily enrolls and signs the informed consent form, and agrees to comply with the study treatment plan and visit schedule.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.