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

Sponsor
Xia Yi
Study ID
NCT06573645
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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

Key Dates

Start date
Aug 23, 2024
Status verified
Aug 2024
Primary completion
Jan 12, 2027
Completion
Jul 12, 2027

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose Rituximab Group
    Patients will be assigned to the trial group (rituximab 500 mg/m2) and will receive six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).
  • Active Comparator: Standard-dose Rituximab Group
    Patients will be assigned to the control group (rituxan 375 mg/m2), the participants will receive 6 cycles R - CHOP treatment (21 d for a cycle), and the subsequent 2 cycle rituxan maintenance therapy (21 d for a cycle)

Primary Outcome Measure

MODIFIED-PFS [ 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 ]

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