A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-75
SponsorXia Yi

About this trial

Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients

Eligibility criteria

Qualifiers

age <75y, male patients

According to the 2017 Revised WHO Classification criteria for lymphoma, the subject was diagnosed with DLBCL

According to Ann Arbor staging, patients were classified as stage III-IV patients

No previous anti-tumor systemic therapy or local radiation therapy for DLBCL

Disqualifiers

Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;

Any previous anti-lymphoma systemic therapy or local radiation therapy

Consider patients with lymphoma involving the central nervous system (CNS) or diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal large B-cell lymphoma (PMBL)

Previously received organ transplantation or hematopoietic stem cell transplantation

Trial design

Treatments tested in this trial

  • Rituximab

Treatment groups

428 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Xia Yi

Lead sponsor

Sun Yat-Sen University Cancer Center

Sponsor institution