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RECRUITING
NCT06251180
PHASE1

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

Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-04-10

Completion Date

2029-12-31

Last Updated

2025-03-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China