DLBCL - Diffuse Large B Cell Lymphoma
Conditions
Keywords
pirtobrutinib, Lisaftoclax, DLBCL
Brief 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.
Interventions
DRUGPirtobrutinib
200mg qd po
DRUGLisaftoclax
cycle 1: 200mg qd d1-7; 400mg qd d8-d28；Cycle 2: 400mg qd d1-d28 po
DRUGRituximab
375mg/m2 d1 intravenous drip
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate(CRR) | 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 |
| Adverse Events | During induction treatment | The safety during induction treatment |
Countries
China
Contacts
Primary ContactChangju Qu
Outcome results
None listed