Actively Recruiting
Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-12-01
29
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Able to understand and voluntarily sign informed consent
- ECOG performance status between 0 and 3
- Expected to live at least 3 months
- Histologically or cytologically confirmed diagnosis of DLBCL
- Measurable disease on PET-CT with short axis diameter of at least 1.5 cm
- Have received at least one prior systemic therapy for DLBCL
- Prior treatment-related non-hematologic toxicities resolved to Grade 1 or baseline
- Adequate bone marrow and organ function, including specific blood counts and liver, kidney, and coagulation parameters
- Willing to use birth control during the study and follow-up if of childbearing potential
- Able to swallow tablets or capsules without difficulty
- Willing to follow scheduled visits, treatments, lab tests, and study procedures
You will not qualify if you...
- Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors
- Recent anticancer therapies within specified washout periods including chemotherapy, radiotherapy, immunotherapy, targeted therapy, ADCs, or cytotoxic therapy
- Participation in another investigational drug study within 4 weeks before starting treatment
- Systemic corticosteroid use exceeding specified doses for CNS disease control within 14 days before treatment
- Need for ongoing anticancer therapy
- Uncontrolled or severe cardiovascular disease
- Active infection requiring intravenous antibiotics or systemic antimicrobial therapy
- Active hepatitis B or C infection except inactive carriers or patients with viral suppression or cure
- Significant abnormalities affecting drug absorption or prior major stomach surgery
- History of bleeding disorders or need for long-term oral anticoagulation
- Prior or planned allogeneic hematopoietic stem cell transplantation
- Pregnant or breastfeeding women
- Known allergy to study drugs or their components
- Active psychiatric illness or history of alcohol or drug abuse
- Any uncontrolled illness or medical condition that may affect safety or adherence
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
C
Changju Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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