Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）

Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

DRUG

Orelabrutinib Oral Tablet

Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen

DRUG

R-CHOP Protocol

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Gansu Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Fifth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• The First People's Hospital of Zhaoqing

  collaborator UNKNOWN

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-11-01

Completion

2027-03-01

Countries

• China

Study Locations