NCT06251180

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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: 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.

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Rocbrutinib	orally once daily in a 21-day cycle for eight cycles, and as maintenance for 2 years.
BIOLOGICAL	Rituximab	375 mg/m2 administered intravenously once on Day 1 in a 21-day cycle for eight cycles.
DRUG	Cyclophosphamide	750 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
DRUG	doxorubicin	50 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
DRUG	Vincristin	1.4 mg/m2 administered intravenously once on Day 1 or 2 in a 21-day cycle for six cycles.
DRUG	Prednisone	100 mg orally once on Day 1 to Day 5 in a 21-day cycle for six cycles.

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2024-02-09
• Last updated: 2025-03-25

Locations

1 site across 1 country: China