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

NCT06251180 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-03-25

No results posted yet for this study

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

Conditions

  • B-cell Non-Hodgkin Lymphoma

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.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Principal Investigators

  • Qingqing Cai, Ph D · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2025-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06251180 on ClinicalTrials.gov