Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor
Ruijin Hospital
Study ID
NCT07122609
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Relapsed and Refractory DLBCL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Dose:200mg，d1-21
  • R-GemOx — DRUG
    Dose: Rituximab: 375mg/m2, d1; Gemcitabine: 1000mg/m2, d2; Oxaliplatin:100mg/m2, d2
  • Polatuzumab Vedotin — DRUG
    Dose: 1.8mg/kg，iv，d1 (For patient who is CD79b positive and has not previously received polatuzumab Vedotin)

Study Details

This is a prospective, single arm trial in patients with ≥ 18 years with relapsed and refractory DLBCL. Aim of this study is to evaluate the efficacy and safety of pirtobrutinib in combination with rituximab, gemcitabine, and oxaliplatin with or without polatuzumab vedotin (Pirto-R-GemOx±pola) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) previously treated with covalent BTK inhibitors.

Key Dates

Start date
Aug 5, 2025
Status verified
Aug 2025
Primary completion
Aug 15, 2026
Completion
Aug 15, 2027

Study Design

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

Arms

  • Experimental: pirtobrutinib+R-GemOx with or without polatuzumab vedotin
    DLBCL patients will receive Pirto-R-GemOx for a total of 6 treatment cycles (21days per cycle). Patient who is CD79b positive and has not previously received polatuzumab Vedotin will combine with polatuzumab Vedotin.The efficacy will be evaluated every 3 cycles, young patients with CR will receive ASCT, CR patients who do not undergo ASCT or PR patients will continued for 3 cycles.If the efficacy is evaluated as CR or PR after 6 cycles, then ASCT for young patients, and lenalidomide maintenance treatment for elderly patients for 2 years (25mg, day 1-21, Q4W). ctDNA testing will be performed at baseline、before the second course、and at the end of treatment.

Primary Outcome Measure

complete response rate(CRR) [ Time Frame: Up to 6 cycles (each cycle is 21 days) ]

Central Contacts