Clinical trial · Interventional
Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
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
NCT07651176CI-TRIAL-00114857enrolling 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 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.
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Lisaftoclax | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin+cytarabine | Drug | — | UNRESOLVED |
| Lisaftoclax+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 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.
- interventionNames
- Drug: Lisaftoclax+daunorubicin+cytarabine
- Drug: Lisaftoclax+cytarabine
- Drug: Lisaftoclax+azacitidine
- type
- EXPERIMENTAL
- label
- Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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; 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.
References
Publications (0)
Data not yet available
No reference posted for this study.