RecruitingPhase 1NCT06251180

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

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


Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Enrollment

112 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

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 Non-Hodgkin Lymphoma \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding rocbrutinib (a BTK inhibitor, which blocks a protein that helps certain cancers grow) to a standard chemotherapy regimen called R-CHOP improves outcomes for people newly diagnosed with certain B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). **You may be eligible if...** - You have been newly diagnosed with DLBCL, MCL, or MZL confirmed by biopsy - You have not previously received any treatment for this cancer - You have at least one measurable tumor on scans - You are in good enough physical condition (ECOG 0–2) - Your organ function is adequate **You may NOT be eligible if...** - You have already received treatment for this lymphoma - You have significant bleeding problems or are on anticoagulants - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding - You have significant heart rhythm problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRocbrutinib

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

BIOLOGICALRituximab

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

DRUGCyclophosphamide

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

DRUGdoxorubicin

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

DRUGVincristin

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

DRUGPrednisone

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


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06251180