Clinical trial · Interventional
Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
Clinical Study Protocol for the Treatment of Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia With KMT2A Gene Abnormalities Using VHEA(Venetoclax With Homoharringtonine,Etoposide,Cytarabine)
- 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 study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA(Venetoclax with Homoharringtonine,Etoposide,Cytarabine)regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax 100 mg d1,200 mg d2,400 mg d3-14; | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VHEA regimen in the treatment of ND-AML and RR-AML with MLL gene abnormalities.
- description
- Venetoclax 100 mg d1,200 mg d2,400 mg d3-14; homoharringtoine, HHT 2 mg/m2,qd,d1-7; Etoposide 0.1 g,qd,d1-5; Cytarabine 100 mg/m2,qd,d1-7 The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- interventionNames
- Drug: Venetoclax 100 mg d1,200 mg d2,400 mg d3-14;
Primary outcomes (1)
- measure
- Overall response rate,ORR
- timeFrame
- The period of 1 year from the start of treatment.
- description
- The morphological efficacy evaluation of the subjects is divided into four outcomes: complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), partial remission (PR), and no remission (NR). Among them, CR, CRh, CRi, MLFS, and PR are collectively referred to as ORR. The evaluation time point is on the 21st day after the start of chemotherapy. When the patient is first evaluated as CR/CRh/CRi, complete test results such as peripheral blood, bone marrow, and clinical symptoms are required.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Expected survival time of at least 3 months. * Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min. * No other significant contraindications to chemotherapy as determined by the physician; * Capable of understanding and willing to sign the informed consent form for this study. Exclusion Criteria: * Presence of other malignancies; * Underwent cardiac vascular intervention or stent placement within 12 months prior to signing the informed consent, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease; * Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding; * Pregnant or lactating women; * Participation in any other clinical study within 3 months prior to signing the informed consent; * Any other condition deemed unsuitable for participation in this study by the investigator.
References
Publications (0)
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