A Prospective Study of Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• ≥18 years old.

• Capable of understanding and voluntarily signing written informed consent.

• ECOG performance 0 \

• Anticipated survival ≥3 months

• Histologically or cytologically confirmed DLBCL.

• PET-CT-defined measurable disease with a short axis diameter of ≥1.5 cm.

• Have received at least one prior line of systemic therapy for DLBCL.

• Resolution of any prior treatment-related non-hematologic toxicities to Grade ≤1 or baseline.

• Adequate Bone Marrow and Organ Function, defined as:

• Bone Marrow Function: ANC≥1.5 × 10⁹/L, Platelets ≥80 × 10⁹/L, Hemoglobin ≥80 g/L Hepatic Function: Total bilirubin ≤1.5 × ULN (≤3.0 × ULN if liver metastases present); AST/SGOT and ALT/SGPT ≤2.5 × ULN (≤5.0 × ULN if liver metastases present) Coagulation: INR and aPTT≤1.5 × ULN Renal Function: Serum creatinine ≤1.5 × ULN or estimated creatinine clearance (CrCl) ≥60 mL/min;

⁃ Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.

⁃ Able to swallow tablets/capsules without difficulty.

⁃ Adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Changju Qu
qcj310@163.com
67781865
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 29
Treatments
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.
Sponsors
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov