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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

ConditionLymphoma, Large B-Cell, Diffuse
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Rituximab

    Drug

    Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).

Treatment groups

428 Participants
are divided into 2 treatment groups
Group A: High-dose Rituximab GroupExperimental treatment 1 intervention
Group B: Standard-dose Rituximab GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MODIFIED-PFS

To investigate the preliminary anti-tumor efficacy

Time frame
From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary outcomes

1

Overall survival (OS)

To investigate the preliminary anti-tumor efficacy

Time frame
From the date of enrollment until the date of death from ant cause, assessed up to 48 months
2

Complete response rate (CRR)

To investigate the preliminary anti-tumor efficacy

Time frame
Up to 8 cycles (each cycle is 21 days)
3

Objective response rate (ORR)

To investigate the preliminary anti-tumor efficacy

Time frame
Up to 8 cycles (each cycle is 21 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xia Yi

Lead sponsor

Sun Yat-Sen University Cancer Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: