Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07255963
Phase
PHASE2
Status
Recruiting
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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    200mg qd po
  • Lisaftoclax — DRUG
    cycle 1: 200mg qd d1-7; 400mg qd d8-d28；Cycle 2: 400mg qd d1-d28 po
  • Rituximab — DRUG
    375mg/m2 d1 intravenous drip

Study Details

This study aims to evaluate the efficacy of combining pirtobrutinib, lisaftoclax, and rituximab (PVR) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy and to explore a more effective treatment strategy for this patient population.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

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

Arms

  • Experimental: Pirtobrutinib, Lisaftoclax, and Rituximab
    R/R DLBCL patients will receive PVR for a total of 2 treatment cycles (28 days per cycle) in the induction treatment. Patients with CR/PR after two cycles recieve consolidation therapy : ASCT or CAR-T or PVR (R for 6 cycles, PV continued until disease progression or intolerable adverse reactions) or radiotherapy.The patient will be followed up for two years.

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: At the end of 2 cycles of PVR regimen (each cycle is 28 days) ]

Central Contacts

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