Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma

Sponsor
Huiqiang Huang
Study ID
NCT04058470
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • ALK-Positive Anaplastic Large Cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • EBV-Positive DLBCL, Nos
  • Follicular Lymphoma Grade IIIb
  • High-grade B-cell Lymphoma
  • Transformed Lymphoma

Eligibility Criteria

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

Interventions

  • Toripalimab, Rituximab — DRUG
    Toripalimab in combination with Rituximab will be administered every 3 weeks up to 4 cycles.
  • R-CHOP Protocol — DRUG
    After toripalimab plus rituximab treatment, R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP up to 6 cycles.

Study Details

1. Phase I portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab in treating untreated elderly diffuse large B cell lymphoma patients. 2. The aim of phase II portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab followed by R-CHOP(rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) regimen in treating untreated elderly diffuse large B cell lymphoma patients.

Key Dates

Start date
Apr 24, 2020
Status verified
Apr 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2025

Study Design

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

Arms

  • Experimental: TR follow by R-CHOP
    TR follow by R-CHOP: TR: Toripalimab,Rituximab, R-CHOP: Rituximab, Cyclophosphamide,Doxorubicin,Vincristine,Prednisone

Primary Outcome Measure

Overall Response Rate (ORR) of toripalimab combined with Rituximab , Investigator-Assessed [ Time Frame: upto 36 months ]

Central Contacts

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