Camrelizumab Plus R-CHOP Regimen in Untreated Primary Extranodal DLBCL

Sponsor
Sun Yat-sen University
Study ID
NCT05093140
Phase
PHASE2
Status
Unknown

Conditions

  • DLBCL
  • Primary Extranodal Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Induction therapy: Camrelizumab 200mg, ivd, D1, Rituximab 375mg/m2, ivd, D1 every 3 weeks up to 2 cycles Immunochemotherapy: Rituximab: 375mg/m2, ivd, D1; Cyclophosphamide: 750mg/m2, iv or ivd, D1; Hydroxyldaunorubicin: 50mg/m2, iv or ivd, D1; Vincristine: 1.4 mg/m2 , iv(max：2mg), D1; Prednisone: 60mg/m2, po, d1-5 every 3 weeks up to 6 cycles Maintenance therapy: Camrelizumab 200mg, ivd, D1 every 4 weeks up to 6 cycles

Study Details

To assess the efficacy and safety of camrelizumab combined with rituximab, vincristine, doxorubicin, cyclophosphamide and prednisone in the treatment of untreated primary extranodal DLBCL

Key Dates

Start date
Jun 1, 2022
Status verified
Apr 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: camrelizumab+R-CHOP
    Induction therapy: camrelizumab in combination with rituximab Immunochemotherapy: rituximab, cyclophosphamide, hydroxyldaunorubicin, vincristine, prednisone Maintenance therapy: camrelizumab in patients achieved CR after immunotherapy

Primary Outcome Measure

complete response rate [ Time Frame: 24 weeks ]

Central Contacts

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