Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05186558
Phase
PHASE2
Status
Unknown

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Neoplasms by Histologic Type

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin — DRUG
    Patients receive penpulimab+R2-GemOx two weeks for a cycle, detailed as follows: Combination therapy Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), for 6 cycles. R2-GemOx: lenalidomide 10 mg，d1-7; Rituximab 375mg/m2, d0; Gemcitabine 1000mg, d1; Oxaliplatin 100mg/m2, d1; every 2 weeks for a cycle, 6 cycles as protocol specified. Maintenance treatment: Combination of two drugs: * Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), , for 6 months * lenalidomide: 10 mg, po, for 18 months.

Study Details

This study evaluates the efficacy and safety of penpulimab plus lenalidomide, rituximab, gemcitabine and oxaliplatin (R2-GemOx) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). All patients will receive six cycles of penpulimab plus R2-GemOx. Afterwards, 1) patients who achieve complete response (CR)/unconfirmed (CRu)/partial response (PR) assessed by positron emission tomography/computedtomography (PET-CT) and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. 2) Patients who achieve CR/CRu/PR assessed by PET-CT and are not eligible for ASCT will directly receive penpulimab and lenalidomide as maintenance treatment, penpulimab for a maximum of 6 months, lenalidomide monotherapy for 18 months. 3) Patients achieved stable disease (SD) or progression disease (PD) assessed by PET-CT will withdraw from this study and receive proper treatment based on investigator's decision.

Key Dates

Start date
May 15, 2022
Status verified
Mar 2022
Primary completion
Jan 15, 2024
Completion
Feb 15, 2026

Study Design

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

Arms

  • Experimental: penpulimab, lenalidomide, rituximab, gemcitabine and oxaliplatin（Penpulimab-R2-GemOx)）
    penpulimab: 200 mg q2w, iv, drip R2-GemOx: lenalidomide 10 mg，po; Rituximab 375mg/m2, iv, drip; Gemcitabine 1000mg, po; Oxaliplatin 100mg/m2, iv, drip;

Primary Outcome Measure

Complete response rate [ Time Frame: 6 weeks after the last dose of the combination therapy (each cycle is 14 days) ]

Central Contacts

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