Clinical trial · Interventional
Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
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
NCT07651163CI-TRIAL-00114974enrolling by invitationPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Lisaftoclax | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lisaftoclax+azacitidine | Drug | — | UNRESOLVED |
| Lisaftoclax+azacitidine or azacitidine | Drug | — | UNRESOLVED |
| Lisaftoclax+ cytarabine | Drug | — | UNRESOLVED |
| Lisaftoclax+daunorubicin+cytarabine | Drug | — | UNRESOLVED |
| Lisaftoclax+homoharringtonine+cytarabine+aclarubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Lisaftoclax+Daunorubicin+Cytarabine
- description
- 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.
- interventionNames
- Drug: Lisaftoclax+daunorubicin+cytarabine
- Drug: Lisaftoclax+ cytarabine
- Drug: Lisaftoclax+azacitidine or azacitidine
- type
- EXPERIMENTAL
- label
- Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.