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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 uppdaterad 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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

450

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

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

Studieorter

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

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

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

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: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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).
Andra namn:
  • Induktionskemoterapi
Läkemedel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andra namn:
  • Konsolideringsbehandling
Läkemedel: 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.
Andra namn:
  • Underhållsbehandling
Experimentell: 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.
Läkemedel: 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).
Andra namn:
  • Induktionskemoterapi
Läkemedel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andra namn:
  • Konsolideringsbehandling
Läkemedel: 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.
Andra namn:
  • Underhållsbehandling
Experimentell: 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.
Läkemedel: Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Andra namn:
  • Konsolideringsbehandling
Läkemedel: 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.
Andra namn:
  • Underhållsbehandling
Läkemedel: Lisaftoclax+azacitidine
Lisaftoclax (200 mg, orally, D1; 400 mg, orally, D2; 600 mg, orally, qd, D3-28) + azacitidine (75 mg/m², D1-7)
Andra namn:
  • Induktionskemoterapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-year overall survival rate (OS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-year event-free survival (EFS) rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

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Sponsor

First Affiliated Hospital of Zhejiang 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 (Faktisk)

1 mars 2026

Primärt slutförande (Beräknad)

1 december 2029

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

11 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CN-ZY-26-02

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