A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

Sponsor
Shanghai Institute Of Biological Products
Study ID
NCT04361279
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • SIBP-02 — DRUG
    Injection，100mg/10ml
  • Rituximab — DRUG
    Injection，100mg/10ml

Study Details

This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China. In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Key Dates

Start date
Jul 25, 2019
Status verified
Dec 2023
Primary completion
May 20, 2022
Completion
May 20, 2022

Study Design

Enrollment
421 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SIBP-02
    Biological: SIBP-02, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks.
  • Active Comparator: Rituximab
    Biological: Rituximab, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: After 6 cycles of treatment, each cycle is 3 weeks ]

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