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

16 maj 2026 uppdaterad av: 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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

51

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Läkemedel: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dose-limiting toxicities (DLTs) (Phase 1b)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Complete response rate (CRR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Up to 24 months
Quality of life will be assessed using the EORTC QLQ-C30 or EQ-5D questionnaire.
Up to 24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sun Yat-sen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 maj 2026

Primärt slutförande (Beräknad)

30 maj 2028

Avslutad studie (Beräknad)

30 november 2028

Studieregistreringsdatum

Först inskickad

16 maj 2026

Först inskickad som uppfyllde QC-kriterierna

16 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B2026-253

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