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

11. juni 2026 oppdatert av: Huafeng Wang, First Affiliated Hospital of Zhejiang University

A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-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 OS rate of the LDA, LHAA, and LA regimens in newly diagnosed patients with intermediate- and high-risk acute myeloid leukemia who are eligible for intensive chemotherapy.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

450

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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 (see Appendix Table 1);
  3. Age 15-65 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A: Lisaftoclax+Daunorubicin+Cytarabine

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

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were classified as post-transplant or non-transplant. Post-transplant patients were randomized 1:1 to receive either lisaftoclax plus azacitidine or azacitidine alone. Non-transplant patients received lisaftoclax in combination with azacitidine.

Maintenance therapy was administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity.
Legemiddel: 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 navn:
  • Induksjonskjemoterapi
Legemiddel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navn:
  • Konsolideringsbehandling
Legemiddel: Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navn:
  • Vedlikeholdsbehandling
Eksperimentell: Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

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

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy.

All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2.
Legemiddel: 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 navn:
  • Induksjonskjemoterapi
Legemiddel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navn:
  • Konsolideringsbehandling
Legemiddel: Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navn:
  • Vedlikeholdsbehandling
Eksperimentell: Arm C:Lisaftoclax+ azacitidine

Participants received induction therapy with lisaftoclax in combination with azacitidine.

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy.

All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2.
Legemiddel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andre navn:
  • Konsolideringsbehandling
Legemiddel: Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Andre navn:
  • Vedlikeholdsbehandling
Legemiddel: Lisaftoclax+azacitidine
Lisaftoclax (200 mg, orally, D1; 400 mg, orally, D2; 600 mg, orally, qd, D3-28) + azacitidine (75 mg/m², D1-7)
Andre navn:
  • Induksjonskjemoterapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
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
Complete Response (CR) rate after 1/2 treatment cycles
Tidsramme: At the end of Cycle 1 or Cycle 2 of 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 of 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 of 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 of 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 of 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 of induction chemotherapy (each cycle is 28 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital of Zhejiang University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

27. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CN-ZY-26-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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