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This is a phase 1b/2a, open-label trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of lisaftoclax in combination with chidamide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisaftoclax in combination with chidamide and rituximab | Experimental | Patients will receive lisaftoclax orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles, with daily dose ramp-up during Cycle 1. Chidamide will be administered orally at 20 mg on Days 1, 4, 8, and 11 of each cycle, and rituximab will be administered intravenously at 375 mg/m² on Day 1 of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisaftoclax | Drug | Lisaftoclax will be administered orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles. During Cycle 1, a daily dose ramp-up schedule will be used. In the 600 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, and 600 mg on Day 3, followed by 600 mg once daily on Days 4-14. In the 800 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, 600 mg on Day 3, and 800 mg on Day 4, followed by 800 mg once daily on Days 5-14. From Cycles 2-6, participants will receive lisaftoclax at the target dose (600 mg or 800 mg) once daily on Days 1-14. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLTs) (Phase 1b) | DLTs will be assessed during the DLT evaluation period and graded according to NCI CTCAE version 5.0. | During the first treatment cycle (21 days) |
| Maximum tolerated dose (MTD) (Phase 1b) | MTD is defined as the highest dose level at which fewer than one-third of patients experience a DLT during the DLT evaluation period. | During the first treatment cycle (21 days) |
| Recommended phase 2 dose (RP2D) (Phase 1b) | RP2D will be determined based on the overall safety, tolerability, and DLT assessment results. | During the first treatment cycle (21 days) |
| Objective response rate (ORR) | ORR is defined as the proportion of patients who achieve complete response or partial response according to Lugano 2014 criteria. | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | CRR is defined as the proportion of patients who achieve complete response according to Lugano 2014 criteria. | Up to approximately 6 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen university cancer center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C000726452 | Lisaftoclax |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Chidamide | Drug | Chidamide will be administered orally at a dose of 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle for up to 6 cycles. |
|
| rituximab | Drug | Rituximab will be administered intravenously at a dose of 375 mg/m² on Day 1 of each 21-day cycle for up to 6 cycles. |
|
DOR is defined as the time from the first documented response to disease progression or death from any cause.
| Up to 24 months |
| Disease-free survival (DFS) | DFS is defined as the time from first documented complete response to disease progression or death from any cause. | Up to 24 months |
| Progression-free survival (PFS) | PFS is defined as the time from enrollment to disease progression or death from any cause. | Up to 24 months |
| Overall survival (OS) | OS is defined as the time from enrollment to death from any cause. | Up to 24 months |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | The incidence and severity of adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | Up to 30 days after the last study treatment |
| Change in Quality of Life | Quality of life will be assessed using the EORTC QLQ-C30 or EQ-5D questionnaire. | Up to 24 months |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |