Mantle Cell LymphomaPhase 3NCT07377578
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 3 study testing Rocbrutinib, Ibrutinib and Acalabrutinib in people with Mantle Cell Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Rocbrutinib, Ibrutinib and Acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesChina
- Study dates
- 5 Feb 2026to 30 Jan 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, 086-010-88196118, SongYQ_VIP@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhigang Peng, 086-13977167015, drpzg001@163.com
Zhigang Peng
About this study
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)
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
- Mantle Cell Lymphoma
- Being tested
- Rocbrutinib, Ibrutinib, Acalabrutinib, Zanubrutinib, Orelabrutinib
- Keywords
- Mantle Cell Lymphoma, BTK inhibitor, Rocbrutinib
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocbrutinibDrug
Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
IbrutinibDrug
Ibrutinib, 560 mg once daily orally and continuously
AcalabrutinibDrug
Acalabrutinib, 100 mg twice daily orally and continuously
ZanubrutinibDrug
Zanubrutinib, 160 mg twice daily orally and continuously
OrelabrutinibDrug
Orelabrutinib, 150 mg once daily orally and continuously
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Rocbrutinib) | Experimental | Not described Receives: Drug: Rocbrutinib |
| Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) | Active comparator | Not described Receives: Drug: Ibrutinib; Drug: Acalabrutinib; Drug: Zanubrutinib; Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by IRC
Measured: approximately 30 months
Secondary outcomes (6)
PFS assessed by INV
Measured: approximately 30 months
Overall Response Rate (ORR) assessed by IRC and INV, respectively
Measured: Up to approximately 24 months
Duration of Response (DOR) assessed by IRC and INV, respectively
Measured: approximately 30 months
Overall Survival
Measured: approximately 40 months
Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0
Measured: Up to approximately 40 months
Number of participants with treatment-related adverse event as assessed by CTCAE v5.0
Measured: Up to approximately 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Feb 2026
- Primary completion30 May 2031 (estimated)
- Study completion30 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377578
- Sponsor's protocol ID
- LP-168-CN302
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07377578
- Acronym / sponsor ID
- LP-168-CN302
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Mantle Cell Lymphoma, BTK inhibitor, Rocbrutinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 May 2031 (estimated)
- Study completion
- 30 Jan 2033 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Rocbrutinib) | Experimental | Drug: Rocbrutinib |
| Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) | Active comparator | Drug: Ibrutinib, Drug: Acalabrutinib, Drug: Zanubrutinib, Drug: Orelabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocbrutinibRocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity | Drug | Arm A (Rocbrutinib) |
| IbrutinibIbrutinib, 560 mg once daily orally and continuously | Drug | Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) |
| AcalabrutinibAcalabrutinib, 100 mg twice daily orally and continuously | Drug | Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) |
| ZanubrutinibZanubrutinib, 160 mg twice daily orally and continuously | Drug | Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) |
| OrelabrutinibOrelabrutinib, 150 mg once daily orally and continuously | Drug | Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) |
Primary outcome
Progression-free survival (PFS) assessed by IRC
Time frame: approximately 30 months
6 secondary outcomes
PFS assessed by INV
Time frame: approximately 30 months
Overall Response Rate (ORR) assessed by IRC and INV, respectively
Time frame: Up to approximately 24 months
Duration of Response (DOR) assessed by IRC and INV, respectively
Time frame: approximately 30 months
Overall Survival
Time frame: approximately 40 months
Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0
Time frame: Up to approximately 40 months
Number of participants with treatment-related adverse event as assessed by CTCAE v5.0
Time frame: Up to approximately 40 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocbrutinib, Ibrutinib and Acalabrutinib in people with Mantle Cell Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song (+86-010-88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by IRC (time frame: approximately 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.