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

November 27, 2025 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years old.
  2. Capable of understanding and voluntarily signing written informed consent.
  3. ECOG performance 0 ~ 3.
  4. Anticipated survival ≥3 months
  5. Histologically or cytologically confirmed DLBCL.
  6. PET-CT-defined measurable disease with a short axis diameter of ≥1.5 cm.
  7. Have received at least one prior line of systemic therapy for DLBCL.
  8. Resolution of any prior treatment-related non-hematologic toxicities to Grade ≤1 or baseline.

  9. 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;

  10. 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.
  11. Able to swallow tablets/capsules without difficulty.
  12. Adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors.
  2. 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.
  3. Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment.
  4. Systemic corticosteroid therapy (>5 days within 14 days prior to treatment) at doses exceeding >10 mg/day dexamethasone (or equivalent) for CNS disease control.
  5. Requiring ongoing anticancer therapy.
  6. Uncontrolled or Severe Cardiovascular Disease,
  7. Active infection requiring IV antibiotics or systemic antimicrobial therapy.
  8. Active HBV/HCV:Exceptions. Inactive HBsAg carriers, HBV patients with sustained viral suppression (HBV-DNA < LLOD),HCV-cured patients are allowed.
  9. Clinically significant abnormalities affecting drug absorption or prior total gastrectomy/gastric banding.
  10. History of hemorrhagic diathesis or requirement for long-term oral anticoagulation.
  11. Prior allogeneic hematopoietic stem cell transplantation (HSCT) or planned allogeneic HSCT.
  12. Women who are pregnant or breastfeeding.
  13. Known allergy to the study drug or its excipients.
  14. Active psychiatric illness or history of alcohol/drug abuse .
  15. Any uncontrolled illness, organ dysfunction, or medical condition that, in the investigator's judgment, jeopardizes patient safety or adherence to study procedures.
  16. Other conditions deemed inappropriate for study participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Pirtobrutinib
200mg qd po
Drug: Lisaftoclax
cycle 1: 200mg qd d1-7; 400mg qd d8-d28；Cycle 2: 400mg qd d1-d28 po
Drug: Rituximab
375mg/m2 d1 intravenous drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: At the end of 2 cycles of PVR regimen (each cycle is 28 days)
The rate of patients who achieved CR or PR after 2 cycles of PVR regimen
At the end of 2 cycles of PVR regimen (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate(CRR)
Time Frame: At the end of 2 cycles of PVR regimen (each cycle is 28 days)
The rate of patients who achieved CR after 2 cycles of PVR regimen
At the end of 2 cycles of PVR regimen (each cycle is 28 days)
Adverse Events
Time Frame: During induction treatment
The safety during induction treatment
During induction treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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