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Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07255963•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

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.
+6 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

November 30, 2025

Primary Completion Date

September 30, 2028

Completion Date

September 30, 2030

Last Updated

December 1, 2025

Enrollment

ESTIMATED participants

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Interventions

Pirtobrutinib

DRUG

Lisaftoclax

DRUG

Rituximab

DRUG

Contacts

Changju Qu

CONTACT

67781865 qcj310@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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