Ibrutinib Combined With Bendamustine and Rituximab in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged > 65 Years

Summary

This study is a prospective observational clinical trial. A total of 19 research centers were involved in this study. Each site plans to enroll 2-3 patients, and a total of 60 patients will be enrolled. Patients who met the diagnosis of mantle cell lymphoma by histological examination, ECOG (Eastern Oncology Collaborative Group) score 0-2, age \>65 years, expected survival of more than 3 months, and at least one measurable lesion were included in this observational clinical trial. In this study, clinical data of patients treated with R-B regimen combined with ibrutinib will be collected, including routine clinical laboratory tests, examinations, and molecular biological data, for efficacy assessment and survival analysis. The main evaluation indicators are the total effective rate of 2 and 6 cycles of alternating R-CHOP/R-DHAP combined with ibrutinib in the treatment of newly treated muff cell lymphoma patients. The 3-year progression-free survival (PFS) and overall survival (OS) of the patients will be assessed, and adverse events to treatment will be collected to evaluate the safety of ibrutinib in combination with untreated mask cell lymphoma.

Conditions

• Mantle Cell Lymphoma (MCL)

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• 307 Hospital of PLA

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• Baotou Cancer Hospital

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Beijing Naval General Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Peking University Third Hospital

  lead OTHER

Principal Investigators

• Hongmei Jing, Professor · Peking University Third Hospital

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-30

Primary Completion

2023-12-30

Completion

2024-07-30

Countries

• China

Study Locations