Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05498259
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Orelabrutinib 150mg qd PO
  • Rituximab — BIOLOGICAL
    Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
  • CHOP-like Regimen — DRUG
    cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.

Study Details

The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients

Key Dates

Start date
Jul 27, 2022
Status verified
Aug 2022
Primary completion
Jan 1, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orelabrutinib+R-CHOP-like
    Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with \<25% tumor reduction, withdraw from the study，treat with R-CHOP-like alone for 6 cycle

Primary Outcome Measure

Complete Response Rate [ Time Frame: At the end of Cycle 6（each cycle is 21 days） ]

Central Contacts

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