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B-cell Non-Hodgkin LymphomaPhase 1NCT06251180

Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma

A Phase 1 study testing Rocbrutinib, Rituximab and Cyclophosphamide in people with B-cell Non-Hodgkin Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site 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, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
B-cell Non-Hodgkin Lymphoma
What is being tested?
Rocbrutinib, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteChina
Study dates
10 Apr 2024to 31 Dec 2029
Phase
Phase 1
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants was histopathologically diagnosed with any of the following diseases: DLBCL, MZL or MCL (if enrolled in the dose expansion phase, histological confirmation of non-GCB subtype), and have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases.
  • Participants must have at least one measurable lesion.
  • ECOG physical status score 0-2.
  • Life expectancy ≥6 months.
  • International Prognostic Index (IPI) score ≥ 2 (only participants with DLBCL in dose expansion portion).
  • Adequate coagulation, liver, kidney, and hematopoietic functions：PT and APTT <1.5x ULN; serum bilirubin <1.5x ULN except in participants with Gilbert's syndrome who must have a serum bilirubin of <3x ULN, AST and ALT ≤ 3x ULN or < 5x ULN if hepatic involvement are present; serum creatinine (Scr) ≤1.5 x ULN, or calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula.; ANC≥1500/mm3, hemoglobin≥8.0 g/dL, and platelets >100,000/mm3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician.
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  • Women of childbearing potential must have a negative serum or urine (beta-human chorionic gonadotropin [beta-hCG]) at screening.
  • Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective contraceptive measures of during and after the study (90 days after the last dose of ROCBRUTINIB and 12 months after the last dose of Rituximab). Men must agree to not donate sperm during and for up to 90 days after he last dose of ROCBRUTINIB.
  • Participants voluntarily enrolled and signed the informed consent form, and followed the trial treatment and visits.

Who cannot join

  • Participants are allergic to Rocbrutinib or any of its excipients; Participants who are assessed by the investigator as being unable to tolerate the R-CHOP regimen.
  • Participants with known central nervous system involvement with lymphoma. or diagnosis of primary central nervous system lymphoma (PCNSL) or primary mediastinal large B-cell lymphoma (PMBL).
  • Participants with DLBCL had a history of indolent lymphoma such as FL or CLL (Richter's transformation), or was histopathologically comfirmed with FL (regardless of grade) coexistentially.
  • Prior treatment with solid organ transplantation or hematopoietic stem cell transplantation(HSCT) ; expected HSCT during the study.
  • Major surgery within 4 weeks of study entry or expected major surgery during the study.
  • Prior another non-antitumor or medical instruments clinical trials within 4 weeks.
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  • Known bleeding diseases (such as von Willebrand's disease or hemophilia A, hemophilia B, etc.), or have bleeding tendency.
  • Prior treatment with warfarin or equivalent vitamin K antagonists within 14 days; requires anticoagulation with warfarin or equivalent vitamin K antagonists.
  • Prior treatment with strong/moderate CYP3A4 inhibitors within 5 days or prior foods with inhibitory effects on CYP3A4 within 3 days at screening; requires chronic treatment with moderate/strong CYP3A inhibitors or inducers, or OATP1B1/OATP1B3 sensitive substrates during the study.
  • Participants with other malignancies other than the target indications of this study within the past three years.
  • Prior treatment with the cumulative dose of doxorubicin ≥150 mg/m2 (or other anthracyclines at doses converted based on cumulative cardiac toxicity)
  • Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure or ≥Class 2 cardiac disease as defined by the New York Heart Association Functional Classification or LVEF less than 40%, uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) > 480 msec, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, COPD, renal failure, severe hepatic disease, uncontrolled active infection, active hemorrhage.
  • Known HIV infection, or syphilis infection, or hepatitis B DNA or hepatitis C RNA positive.
  • Known diseases that affect drug swallowing or absorption.
  • Unfit to participate in this study in the investigator's opinion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL

This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma [Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)].

Read the detailed description

OUTLINE:

Dose escalation portion(Part A): In the dose escalation portion of the study, the escalating doses of Rocbrutinib combined with R-CHOP may be explored, using the 3+3 principle for dose determination. If dose escalation is acceptable, and subsequently will determine the recommended Phase 2 dose.

Dose expansion portion(Part B): This will be conducted as a multicenter, open-label study, including three cohorts(Cohort 1: non-GCB DLBCL; Cohort 2: MZL; Cohort 3: MCL). Eligible subjects will receive Rocbrutinib combined with R-CHOP for 6 cycles, then Rocbrutinib plus Rituximab for 2 cycles, and followed by Rocbrutinib maintenance for 2 years.

After completion of study treatment, patients are followed up every 12 weeks for 1 year, then every 24 weeks for 4 year.

PRIMARY OBJECTIVES:

  1. To evaluate the safety of Rocbrutinib in combination to R-CHOP in B-cell Non-Hodgkin Lymphoma, including the maximum tolerated dose (MTD), dose limiting toxicities(DLT), adverse events (AEs), clinically significant laboratory abnormalities.
  2. To determine the recommended dose. 3. To determine the pharmacokinetic characteristics of Rocbrutinib in combination to R-CHOP.

SECONDARY OBJECTIVES:

  1. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in DLBCL/ Non-germinal Center(non-GCB) DLBCL.
  2. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in MZL.
  3. To determine the overall response rate, the complete response rate, duration of remission, survival outcomes (progression free survival, event free survival, overall survival) in MCL.
Being tested
Rocbrutinib, Rituximab, Cyclophosphamide, doxorubicin, Vincristin
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocbrutinibDrug

    Also called LP-168

    orally once daily in a 21-day cycle for eight cycles, and as maintenance for 2 years.

  • RituximabBiological

    Also called MabThera; Rituximab Biosimilar HLX01; Rituximab biosimilar TQB2303; Henlius; Halpryza

    375 mg/m2 administered intravenously once on Day 1 in a 21-day cycle for eight cycles.

  • CyclophosphamideDrug

    Also called CTX

    750 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.

  • doxorubicinDrug

    Also called ADM; Adriamycin; DOX; Doxorubin hydrochloride

    50 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.

  • VincristinDrug

    Also called VCR; Vincrystine

    1.4 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.

  • PrednisoneDrug

    Also called delta.1-Cortisone; 1, 2-Dehydrocortisone

    100 mg orally once on Day 1 to Day 5 in a 21-day cycle for six cycles.

Study groups in NCT06251180
Study groupRoleWhat they receive
Dose EscalationExperimentalPatients with DLBCL or MCL or MZL receive Rocbrutinib（at escalating dose）+R-CHOP
Receives: Drug: Rocbrutinib; Biological: Rituximab; Drug: Cyclophosphamide; Drug: doxorubicin; Drug: Vincristin; Drug: Prednisone
Dose Expansion [non-GCB DLBCL]ExperimentalPatients with non-GCB DLBCL receive Rocbrutinib（at recommended dose )+R-CHOP
Receives: Drug: Rocbrutinib; Biological: Rituximab; Drug: Cyclophosphamide; Drug: doxorubicin; Drug: Vincristin; Drug: Prednisone
Dose Expansion [MCL]ExperimentalPatients with MCL receive Rocbrutinib（at recommended dose )+R-CHOP
Receives: Drug: Rocbrutinib; Biological: Rituximab; Drug: Cyclophosphamide; Drug: doxorubicin; Drug: Vincristin; Drug: Prednisone
Dose Expansion [MZL]ExperimentalPatients with MZL receive Rocbrutinib（at recommended dose )+R-CHOP
Receives: Drug: Rocbrutinib; Biological: Rituximab; Drug: Cyclophosphamide; Drug: doxorubicin; Drug: Vincristin; Drug: Prednisone

What is being measured

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

  1. MTD

    Standard phase I 3+3 design.

    Measured: Up to 21 days after the initial dose

  2. Recommended Dose

    Recommended Dose will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.

    Measured: Up to 1.5 years

  3. Incidence of AEs

    Type, frequency and severity of AEs, relationship of AEs to study treatment Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Type, frequency and severity of AEs, relationship of AEs to study treatment Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

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

  4. Incidence of clinically significant laboratory abnormalities

    Clinically significant abnormalities in hematology, chemistry, coagulation and urinalysis.

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

  5. Cmax of Rocbrutinib

    Maximum plasma concentration (Cmax) of Rocbrutinib.

    Measured: Up to 24 hours post dose

  6. Tmax of Rocbrutinib

    Time to maximum plasma concentration (Tmax) of Rocbrutinib.

    Measured: Up to 24 hours post dose

  7. T1/2 of Rocbrutinib

    The terminal elimination half-life (t1/2).

    Measured: Up to 24 hours post dose

  8. AUC0-t of Rocbrutinib

    Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration of Rocbrutinib.

    Measured: Up to 24 hours post dose

  9. CL/F of Rocbrutinib

    Apparent clearance (CL/F) of Rocbrutinib.

    Measured: Up to 24 hours post dose

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Assessment using the Lugano Response Criteria for Malignant Lymphoma.

    Measured: Evey 2 cycles for 8 cycles, and followed every 3cyles for 24 months

  2. Complete remission (CR)

    Assessment using the Lugano Response Criteria for Malignant Lymphoma.

    Measured: Evey 2 cycles for 8 cycles, and followed every 3cyles for 24 months

  3. Duration of Response(DOR)

    DOR is defined as the number of days from the date of the first remission to the date of earliest disease progression or death.

    Measured: Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 5 years.

  4. Progression-Free Survival(PFS)

    PFS is defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death.

    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 5 years.

  5. Event-free Survival (EFS)

    EFS is defined as the number of days from the date of first dose to the date of earliest evidence of disease progression/relapse, or initiation of new non-protocol-specified antitumor therapy without documented progression, or death.

    Measured: Measured from the date of first dose to the date of earliest evidence of disease progression, initiation of new non-protocol-specified antitumor therapy without documented progression, death, and for up to 5 years after the last subject is enrolled.

  6. Overall survival (OS)

    OS is defined as the number of days from the date of first dose to the date of death.

    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.

Timeline

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

  1. First posted9 Feb 2024
  2. Study start10 Apr 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2029 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251180
Sponsor's protocol ID
LP-168-CN301
Status last verified
Sep 2026
First submitted
1 Feb 2024
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Younes A, Thieblemont C, Morschhauser F, Flinn I, Friedberg JW, Amorim S, Hivert B, Westin J, Vermeulen J, Bandyopadhyay N, de Vries R, Balasubramanian S, Hellemans P, Smit JW, Fourneau N, Oki Y. Combination of ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treatment-naive patients with CD20-positive B-cell non-Hodgkin lymphoma: a non-randomised, phase 1b study. Lancet Oncol. 2014 Aug;15(9):1019-26. doi: 10.1016/S1470-2045(14)70311-0. Epub 2014 Jul 17.

    PubMed 25042202

  • Younes A, Sehn LH, Johnson P, Zinzani PL, Hong X, Zhu J, Patti C, Belada D, Samoilova O, Suh C, Leppa S, Rai S, Turgut M, Jurczak W, Cheung MC, Gurion R, Yeh SP, Lopez-Hernandez A, Duhrsen U, Thieblemont C, Chiattone CS, Balasubramanian S, Carey J, Liu G, Shreeve SM, Sun S, Zhuang SH, Vermeulen J, Staudt LM, Wilson W; PHOENIX investigators. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019 May 20;37(15):1285-1295. doi: 10.1200/JCO.18.02403. Epub 2019 Mar 22.

    PubMed 30901302

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rocbrutinib, Rituximab and Cyclophosphamide in people with B-cell Non-Hodgkin Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site 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 9 inclusion and 15 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

MTD (time frame: Up to 21 days after the initial dose). The study lists 9 primary outcomes in all. 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 NCT06251180, which also lists 2 linked publications.

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 11 Sep 2026.

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