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

ConditionRelapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Histologically confirmed diffuse large B-cell lymphoma (DLBCL) according to the 2016 WHO classification with BCL-2 positivity by immunohistochemistry (defined as BCL-2 expression ≥30%).

Relapsed or refractory DLBCL after prior treatment with an anthracycline-containing regimen and an anti-CD20 antibody-containing regimen.

Received at least one prior line of therapy and considered ineligible for autologous stem cell transplantation (ASCT).

Disqualifiers

Central nervous system (CNS) involvement by lymphoma, primary CNS lymphoma, or leukemic phase lymphoma.

Prior intolerance to BCL-2 inhibitors and chidamide, or disease refractory to or relapsed after treatment with both agents.

Known hypersensitivity to any component of the study drugs or their analogs.

Prior allogeneic hematopoietic stem cell transplantation within 6 months before the first dose, active graft-versus-host disease (GvHD), or requirement for immunosuppressive therapy within 28 days prior to study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

51 Participants
are divided into 1 treatment group
Group A: Lisaftoclax in combination with chidamide and rituximabExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: