Rocbrutinib versus other BTK inhibitors for relapsed or refractory mantle cell lymphoma
Official title: 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)
Run by Guangzhou Lupeng Pharmaceutical Company LTD. · NCT07377578 · Data updated 2026-11-12
This trial tests whether rocbrutinib works better than other BTK inhibitors for people with mantle cell lymphoma that returned or didn't respond after at least one prior treatment and who have not previously received a BTK inhibitor (except for intolerance).
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 394 (estimated) |
| Sponsor | Guangzhou Lupeng Pharmaceutical Company LTD. Industry-sponsored |
| Drugs / interventions | Rocbrutinib, ibrutinib, acalabrutinib, zanubrutinib, orelabrutinib |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | February 5, 2026 |
| Main results expected | May 30, 2031 |
| Study ends | January 30, 2033 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07377578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with mantle cell lymphoma who progressed after at least one prior systemic regimen, have measurable disease, an ECOG performance status of 0–2, adequate organ function, and have not previously received a BTK inhibitor (except for intolerance).
✕Probably not a fit
People who have already been treated with a BTK inhibitor (unless stopped due to intolerance), those with poor performance status or significant organ dysfunction, pregnant or breastfeeding women, or those unable to attend study visits are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Rocbrutinib is a novel, fourth-generation BTK inhibitor with both covalent and non-covalent binding that showed promising efficacy and a favorable safety profile in earlier Phase 1 and 2 studies. This randomized, open-label Phase 3 trial assigns patients to rocbrutinib or investigator's choice of an approved BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib). Eligible participants have relapsed or refractory mantle cell lymphoma, at least one measurable lesion, prior systemic therapy, and are BTK-inhibitor naïve except for intolerance. The study follows patients for treatment response and safety at sites in China under sponsorship from Guangzhou Lupeng Pharmaceutical.
Why it matters
Potential benefit: If successful, rocbrutinib could offer improved disease control or a more tolerable side-effect profile compared with existing BTK inhibitors for people with relapsed or refractory MCL.
How similar studies have gone: Approved BTK inhibitors have established benefit in MCL and early Phase 1/2 data for rocbrutinib were promising, but direct Phase 3 head-to-head comparisons with other BTK inhibitors are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Hypersensitivity to Rocbrutinib or any study drug in the control group. * Prior treatment with any BTK-targeted therapy (except for intolerance). * Central nervous system (CNS) involvement by lymphoma. * 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. * History of major cardiovascular events within 6 months prior to randomization. * 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. * Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.
Where it's running
-
Beijing Cancer hospital
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Not yet recruiting
Study contacts
- Study coordinator: Yuqin Song
- Email: SongYQ_VIP@163.com
- Phone: +86-010-88196118
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Rocbrutinib in PRL-Positive Relapsing-Remitting MS
This study tests whether Rocbrutinib can help people with relapsing-remitting MS who have paramagnetic rim lesions, compared to dimethyl fumarate.
-
Rocbrutinib and Lacutoclax in B-cell cancers
This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.
-
Rocbrutinib plus R-GemOx for relapsed/refractory DLBCL
This early-stage study tests whether combining Rocbrutinib with R-GemOx is safe and shows promise in people with relapsed or refractory non-GCB DLBCL.
-
Glofitamab for mantle cell lymphoma after CAR-T failure
This phase 2, multicenter, single-arm study tests glofitamab in adults with mantle cell lymphoma who did not respond to or relapsed after CAR-T cell therapy.
-
Effects of itraconazole or rifampin on rocbrutinib levels in healthy adults.
This test will see if the antifungal itraconazole or the antibiotic rifampin change how rocbrutinib is absorbed, distributed, and cleared in healthy adults.
-
Rocbrutinib versus pirtobrutinib for adults with relapsed or refractory CLL/SLL after a covalent BTK inhibitor
This compares rocbrutinib and pirtobrutinib to see which works better and is safer for adults whose CLL or SLL returned or didn't respond after a covalent BTK inhibitor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.