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

16. maj 2026 opdateret af: Qingqing Cai, Sun Yat-sen University

A Phase Ib/IIa Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Lisaftoclax in Combination With Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients（CLARITY 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

51

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun Yat-sen University Cancer Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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).
  • Estimated life expectancy ≥3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • At least one measurable or evaluable lesion according to the Lugano 2014 lymphoma response criteria.
  • Adequate bone marrow, hepatic, and renal function.
  • Ability to understand and willingness to voluntarily sign a written informed consent form.

Exclusion Criteria:

  • 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.
  • Clinically significant active cardiovascular disease.
  • Uncontrolled or clinically unstable infection requiring parenteral antibacterial, antiviral, or antifungal therapy within 7 days before the first dose of study treatment.
  • Pregnant or breastfeeding women.
  • Active human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
  • Malabsorption syndrome or other conditions that may interfere with enteral administration or absorption of study drugs.
  • Any other medical, psychiatric, or social condition that, in the investigator's judgment, would make the subject inappropriate for participation in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Lisaftoclax
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.
Medicin: Chidamide
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.
Medicin: rituximab
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose-limiting toxicities (DLTs) (Phase 1b)
Tidsramme: During the first treatment cycle (21 days)
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)
Tidsramme: During the first treatment cycle (21 days)
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)
Tidsramme: During the first treatment cycle (21 days)
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)
Tidsramme: Up to approximately 6 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete response rate (CRR)
Tidsramme: Up to approximately 6 months
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)
Tidsramme: Up to 24 months
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)
Tidsramme: Up to 24 months
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)
Tidsramme: Up to 24 months
PFS is defined as the time from enrollment to disease progression or death from any cause.
Up to 24 months
Overall survival (OS)
Tidsramme: Up to 24 months
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)
Tidsramme: Up to 30 days after the last study treatment
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
Tidsramme: Up to 24 months
Quality of life will be assessed using the EORTC QLQ-C30 or EQ-5D questionnaire.
Up to 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

30. maj 2028

Studieafslutning (Anslået)

30. november 2028

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

16. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2026-253

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Kliniske forsøg med Recidiverende eller refraktært diffust stort B-cellet lymfom (R/R DLBCL)

Kliniske forsøg med Lisaftoclax

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