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Mantle Cell Lymphoma (MCL)Phase 2NCT05716087

A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

A Phase 2 study testing Rocbrutinib in people with Mantle Cell Lymphoma (MCL), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 43 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma (MCL)
What is being tested?
Rocbrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
43 sitesChina
Study dates
21 Feb 2023to 30 Jun 2026
Phase
Phase 2
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

  • Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
  • At least one measurable lesion.
  • Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20.
  • ECOG≤2.
  • Adequate hematologic function.
  • Adequate hepatic and renal function.
  • Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.

Who cannot join

  • Received non-covalent BTK inhibitor treatment.
  • Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
  • Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
  • Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
  • Disease affects the central nervous system.
  • Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • Affiliated hospital of hebei university

    Baoding

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100089

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Boren Hospital

    Beijing

  • Beijing Friendship hospital

    Beijing

  • The First Bethune Hospital of Jilin University

    Changchun

  • Hunan cancer hospital

    Changsha, Hunan

  • West China School of Medicine

    Chengdu, Sichuan

  • Sichuan Cancer Hospital

    Chengdu

  • The first affiliated hospital of Chongqing mediacal university

    Chongqing, Chongqing Municipality

  • The second hospital of dalian medical university

    Dalian, Liaoning

  • The First People's Hospital of Foshan

    Foshan

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Fujian Medical university union hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital, Southern Medical University

    Guangzhou

  • Sun Yat-sen Memorial Hospital

    Guangzhou

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin First Hospital

    Harbin, Heilongjiang

  • Anhui provincial cancer hospital

    Hefei, Anhui

  • The first affiliated hospital of Anhui medical university

    Hefei, Anhui

  • Qilu hospital of Shandong university

    Jinan, Shandong

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Gansu provincial cancer hospital

    Lanzhou, Gansu

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan

  • Meizhou people'shospital

    Meizhou, Guangdong

  • The first affiliated hospital of Nanchang university

    Nanchang, Jiangxi

  • Jiangsu cancer hospital

    Nanjing, Jiangsu

  • Jiangsu province hospital

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Shengjing hospital of China medical university

    Shenyang, Liaoning

  • The first hospital of China medical university

    Shenyang, Liaoning

  • The fourth hospital of Hebei medical university

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Hematonosis Hospital

    Tianjin, Tianjin Municipality

  • Tianjin medical university cancer hospital

    Tianjin, Tianjin Municipality

  • The first affiliated hospital of Wenzhou medical university

    Wenzhou

  • Hubei Cancer Hospital

    Wuhan

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

  • The first affiliated hospital of Xiamen university

    Xiamen, Fujian

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan provincial people's hospital

    Zhengzhou, Henan

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan

Other trials in China

About this study

Official title: An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma

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.

Being tested
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

    Also called NWP-775, LP-168

    Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.

Study groups in NCT05716087
Study groupRoleWhat they receive
RocbrutinibExperimentalSubjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Receives: Drug: Rocbrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).

    Measured: Up to 24 Months

Secondary outcomes (12)

  1. Overall Response Rate

    To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator.

    Measured: Up to 24 Months

  2. Complete remission rate

    To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC.

    Measured: Up to 24 Months

  3. Progression Free Survival

    To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC.

    Measured: Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.

  4. Overall survival

    To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC.

    Measured: Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.

  5. Duration of Response (DOR)

    To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC.

    Measured: Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.

  6. Time to Response (TTR)

    To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC.

    Measured: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.

  7. Safety Assessment

    To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0

    Measured: From first dose of study drug to 28 days after last dose of study drug

  8. Maximum Observed Plasma Concentration (Cmax)

    Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib

    Measured: Up to 24 hours post dose

  9. Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)

    PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib

    Measured: Up to 24 hours post dose

  10. Maximum Observed Plasma Concentration (Tmax)

    PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib

    Measured: Up to 24 hours post dose

  11. Half-life period (T1/2)

    PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib

    Measured: Up to 24 hours post dose

  12. Quality of life (QoL)

    Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start21 Feb 2023
  3. Primary completion5 Dec 2024
  4. Study completion30 Jun 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716087
Sponsor's protocol ID
LP-168-CN201
Status last verified
Jan 2026
First submitted
19 Jan 2023
Last updated
15 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rocbrutinib in people with Mantle Cell Lymphoma (MCL), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 43 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716087.

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 15 Jan 2026.

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