Neoplasms

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Lymphoma, B-Cell

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Neoplasms by Histologic Type

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Patients with DLBCL or MCL or MZL receive Rocbrutinib（at escalating dose）+R-CHOP

Patients with non-GCB DLBCL receive Rocbrutinib（at recommended dose )+R-CHOP

Patients with MCL receive Rocbrutinib（at recommended dose )+R-CHOP

Patients with MZL receive Rocbrutinib（at recommended dose )+R-CHOP

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

Rocbrutinib

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

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

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

doxorubicin

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

Vincristin

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

Yue Shen, Ph D

Qingqing Cai, M.D.

Qingqing Cai, Ph D

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

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:

I. 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:

I. 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.

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

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

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

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

Maximum plasma concentration (Cmax) of Rocbrutinib.

Time to maximum plasma concentration (Tmax) of Rocbrutinib.

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

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

Apparent clearance (CL/F) of Rocbrutinib.

Assessment using the Lugano Response Criteria for Malignant Lymphoma.

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

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma	NCT06251180	B-cell Non-Hodg...	Rocbrutinib Rituximab Cyclophosphamid... doxorubicin Vincristin Prednisone	18 Years - 70 Years	Guangzhou Lupeng Pharmaceutical Company LTD.
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma	NCT06251180	B-cell Non-Hodg...	Rocbrutinib Rituximab Cyclophosphamid... doxorubicin Vincristin Prednisone	18 Years - 70 Years	Guangzhou Lupeng Pharmaceutical Company LTD.

Spots Global Cancer Trial Database for rocbrutinib

Every month we try and update this database with for rocbrutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rocbrutinib

Every month we try and update this database with for rocbrutinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rocbrutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.