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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib, Lisaftoclax, and Rituximab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | 200mg qd po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) | 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 | The safety during induction treatment |
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Inclusion Criteria:
≥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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changju Qu | Contact | 67781865 | qcj310@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33900450 | Background | Zhou Z, Zhang L, Wang X, Li X, Li L, Fu X, Zhang X, Li Z, Sun Z, Zhang M. Ibrutinib combined with venetoclax for the treatment of relapsed/refractory diffuse large B cell lymphoma. Ann Hematol. 2021 Jun;100(6):1509-1516. doi: 10.1007/s00277-021-04535-7. Epub 2021 Apr 26. | |
| 38861666 | Background | Roeker LE, Woyach JA, Cheah CY, Coombs CC, Shah NN, Wierda WG, Patel MR, Lamanna N, Tsai DE, Nair B, Wang C, Zhao X, Liu D, Radtke D, Chapman S, Marella N, McNeely SC, Brown JR. Fixed-duration pirtobrutinib plus venetoclax with or without rituximab in relapsed/refractory CLL: the phase 1b BRUIN trial. Blood. 2024 Sep 26;144(13):1374-1386. doi: 10.1182/blood.2024024510. |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
| C000726452 | Lisaftoclax |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Lisaftoclax |
| Drug |
cycle 1: 200mg qd d1-7; 400mg qd d8-d28;Cycle 2: 400mg qd d1-d28 po |
|
| Rituximab | Drug | 375mg/m2 d1 intravenous drip |
|
| During induction treatment |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |