Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma

Browse trials for

• Recurrence 4,278
• Lymphoma, Large B-Cell, Diffuse 1,389

Recurrence

4,278 studies on the registry are indexed under Recurrence; 987 are open to participants now.

This study's planned enrollment of 51 is close to the median of 50 across 3,373 interventional studies indexed under Recurrence.

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Study arms

• Experimental
  Lisaftoclax in combination with chidamide and rituximab

  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.

  Drug: Lisaftoclax · Drug: Chidamide · Drug: rituximab

Interventions

• DrugLisaftoclax

  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.

• DrugChidamide

  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.

• Drugrituximab

  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.

Primary outcomes

1. Dose-limiting toxicities (DLTs) (Phase 1b)

   DLTs will be assessed during the DLT evaluation period and graded according to NCI CTCAE version 5.0.

   Time frame: During the first treatment cycle (21 days)

2. 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.

   Time frame: During the first treatment cycle (21 days)

3. Recommended phase 2 dose (RP2D) (Phase 1b)

   RP2D will be determined based on the overall safety, tolerability, and DLT assessment results.

   Time frame: During the first treatment cycle (21 days)

4. Objective response rate (ORR)

   ORR is defined as the proportion of patients who achieve complete response or partial response according to Lugano 2014 criteria.

   Time frame: Up to approximately 6 months

Secondary outcomes

1. Complete response rate (CRR)

   CRR is defined as the proportion of patients who achieve complete response according to Lugano 2014 criteria.

   Time frame: Up to approximately 6 months

2. Duration of response (DOR)

   DOR is defined as the time from the first documented response to disease progression or death from any cause.

   Time frame: Up to 24 months

3. Disease-free survival (DFS)

   DFS is defined as the time from first documented complete response to disease progression or death from any cause.

   Time frame: Up to 24 months

4. Progression-free survival (PFS)

   PFS is defined as the time from enrollment to disease progression or death from any cause.

   Time frame: Up to 24 months

5. Overall survival (OS)

   OS is defined as the time from enrollment to death from any cause.

   Time frame: Up to 24 months

6. 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.

   Time frame: Up to 30 days after the last study treatment

7. Change in Quality of Life

   Quality of life will be assessed using the EORTC QLQ-C30 or EQ-5D questionnaire.

   Time frame: Up to 24 months

Individual participant data

Plan to share: No