Pirtobrutinib, lisaftoclax and rituximab for relapsed or refractory diffuse large B-cell lymphoma

Trial details

Who runs it

The First Affiliated Hospital of Soochow University

Trial code

NCT07255963

Record updated

1 December 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: ≥18 years old; Capable of understanding and voluntarily signing written informed consent; ECOG performance 0 ~ 3; 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.

Exclusion: Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors; Prior Anticancer Therapy:Chemotherapy, radiotherapy, immunotherapy, or antibody-based anticancer therapy within the specified washout period.Traditional Chinese herbal medicine with antitumor indications.Small-molecule targeted therapy within 2 weeks before study treatment initiation. ADCs or cytotoxic therapy within 10 weeks before study treatment initiation; Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment; Systemic corticosteroid therapy (>5 days within 14 days prior to treatment) at doses exceeding >10 mg/day dexamethasone (or equivalent) for CNS disease control; Requiring ongoing anticancer therapy; Clinically significant abnormalities affecting drug absorption or prior total gastrectomy/gastric banding; Prior allogeneic hematopoietic stem cell transplantation (HSCT) or planned allogeneic HSCT; Uncontrolled or Severe Cardiovascular Disease,; Active infection requiring IV antibiotics or systemic antimicrobial therapy; Active HBV/HCV:Exceptions. Inactive HBsAg carriers, HBV patients with sustained viral suppression (HBV-DNA < LLOD),HCV-cured patients are allowed; History of hemorrhagic diathesis or requirement for long-term oral anticoagulation; Known allergy to the study drug or its excipients; Active psychiatric illness or history of alcohol/drug abuse ; Any uncontrolled illness, organ dysfunction, or medical condition that, in the investigator's judgment, jeopardizes patient safety or adherence to study procedures; Other conditions deemed inappropriate for study participation by the investigator; Women who are pregnant or breastfeeding.

ClinicalTrials.gov NCT07255963