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Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

11. juni 2026 opdateret af: Huafeng Wang, First Affiliated Hospital of Zhejiang University

A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

This is a phase II/III, multicenter, randomized, three-arm, open-label, parallel controlled trial. The primary objective of this study is to compare the 2-years EFS rate of the LDA, LHAA, and DA regimens in newly diagnosed patients with low-risk acute myeloid leukemia who are eligible for intensive chemotherapy.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

267

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • The First Affiliated Hospital of Zhejiang University

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:

  1. Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
  2. Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification;
  3. Age 18-65 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  5. Adequate hepatic and renal function: total bilirubin ≤2 mg/dL (35 μmol/L); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× the upper limit of normal; serum creatinine ≤177 μmol/L;
  6. Normal cardiac function, defined as left ventricular ejection fraction (LVEF) >50%;
  7. Life expectancy ≥3 months;
  8. Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.

Exclusion Criteria:

  1. Acute promyelocytic leukemia;
  2. Central nervous system involvement by leukemia;
  3. History of other malignancies within the past 5 years;
  4. Positive for human immunodeficiency virus (HIV);
  5. Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina;
  6. Ineligible for intensive chemotherapy due to poor general condition;
  7. Pregnant or breastfeeding women;
  8. Inability to understand or comply with the study protocol;
  9. Inability to take oral medication or presence of malabsorption syndrome;
  10. Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study;
  11. Inability or unwillingness to provide written informed consent.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: Lisaftoclax+Daunorubicin+Cytarabine

Participants received induction chemotherapy with lisaftoclax, daunorubicin, and cytarabine.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Medicin: Lisaftoclax+daunorubicin+cytarabine
Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Andre navne:
  • Induktionskemoterapi
Medicin: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navne:
  • Konsolideringsbehandling
Medicin: Lisaftoclax+azacitidine
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navne:
  • Vedligeholdelsesbehandling
Eksperimentel: Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

Participants received induction chemotherapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Medicin: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navne:
  • Konsolideringsbehandling
Medicin: Lisaftoclax+azacitidine
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navne:
  • Vedligeholdelsesbehandling
Medicin: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + homoharringtonine (2 mg/m², qd, intramuscular injection or iv infusion, D1-5) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-5) + aclarubicin (12 mg/m², maximum 20 mg, iv, D1-5).
Andre navne:
  • Induktionskemoterapi
Aktiv komparator: Arm C: Daunorubicin+cytarabine

Participants received induction chemotherapy with daunorubicin and cytarabine.

Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen.

Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles.

After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy.

Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first.
Medicin: Lisaftoclax+cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navne:
  • Konsolideringsbehandling
Medicin: Lisaftoclax+azacitidine
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navne:
  • Vedligeholdelsesbehandling
Medicin: Daunorubicin+cytarabine
Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Andre navne:
  • Induktionskemoterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2-year event-free survival (EFS) rate
Tidsramme: from randomization up to 2 years after randomization
defined as the proportion of patients remaining free of treatment failure, hematologic relapse, MRD relapse, or death within 2 years after randomization.
from randomization up to 2 years after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Response (CR) rate after 1/2 treatment cycles
Tidsramme: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving complete response (CR) after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
Composite Complete Response (CRc) rate after 1/2 treatment cycles
Tidsramme: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy
Tidsramme: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
defined as the the proportion of patients with negative minimal residual disease (MRD) among patients who achieve complete remission after 1-2 cycles of induction chemotherapy
At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
2-year overall survival rate (OS)
Tidsramme: from randomization up to 2 years
defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later
from randomization up to 2 years
2-year relapse-free survival (RFS) rate
Tidsramme: from the date of complete remission (CR/CRi) up to 2 years after achieving response
defined as the proportion of patients who achieved complete response (CR) or complete remission with incomplete hematologic recovery (CRi) and remained alive without disease relapse within 2 years after achieving response.
from the date of complete remission (CR/CRi) up to 2 years after achieving response
Safety and Tolerability
Tidsramme: up to 24 months
defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0
up to 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

First Affiliated Hospital of Zhejiang 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 (Faktiske)

1. marts 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CN-ZY-26-01

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Lisaftoclax+daunorubicin+cytarabine

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