Venetoclax, Azacitidine and Homoharringtonine Before Transplant for Relapsed or Refractory AML
Tests venetoclax, azacitidine and homoharringtonine before stem cell transplant in relapsed or refractory AML.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of VAH as a Bridging Regimen to Allo-HCT in Relapsed/Refractory AML
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 14 to 70 with acute myeloid leukemia (AML) that came back or did not respond to treatment, who are going on to a stem cell transplant from a donor. They get a three-drug combination (VAH) before the transplant.
- Age
- 14 to 70 years
- Sex
- All sexes can join.
- Disease stage
- AML that came back after remission (relapsed) or did not respond to treatment (refractory). For RUNX1::RUNX1T1 AML: leftover disease after the second consolidation therapy, or less than a 3-log fall in the fusion gene.
- Earlier treatment
- Refractory means no response after two courses of standard induction therapy, relapse within 12 months after consolidation, no response to chemotherapy after a later relapse, or two or more relapses. Relapse means leukemia came back after complete remission.
- Biomarker or test result
- For RUNX1::RUNX1T1 AML: leftover disease on bone marrow testing and/or less than a 3-log fall in the RUNX1::RUNX1T1 fusion gene. Other AML types are not tied to a marker.
Main reasons for not taking part
- Allergy to any of the study drugs
- Serious active heart disease, or a heart attack in the past 6 months
- Serious illness such as ongoing infection or uncontrolled diabetes
- Active autoimmune disease such as SLE or rheumatoid arthritis
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 70 years old?
Source: NCT07091006, who can take part
Where in China
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaContact: Xiaoxia HUNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07091006
- Record updated
- 29 July 2025
- Original description
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed/refractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed/refractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed/refractory AML.Read full original descriptionShow less
A Prospective Study on the Efficacy and Safety of Venetoclax, Azacitidine, and Homoharringtonine (VAH) Combination as a Bridging Regimen to Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed/Refractory Acute Myeloid Leukemia
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed/refractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed/refractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed/refractory AML.
Inclusion: Aged 14 to 70 years (inclusive), regardless of gender; The diagnosis of AML was confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests; Relapsed AML: After achieving complete remission (CR), the reappearance of leukemic cells in peripheral blood, or ≥5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration by leukemic cells; Refractory AML: Newly diagnosed cases that are unresponsive after two courses of standard induction therapy; patients who relapse within 12 months after consolidation/intensification therapy post-CR; patients who relapse after 12 months but fail to respond to conventional chemotherapy; patients with two or more relapses; or those with persistent extramedullary leukemia; With RUNX1::RUNX1T1 AML: Positive measurable residual disease (MRD) on bone marrow flow evaluation after the second consolidation therapy and/or less than a 3-log decrease in the RUNX1::RUNX1T1 fusion gene and diagnostic baseline values; ECOG score ≤2; HCT-CI score <3; Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN); Alanine aminotransferase (ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN; Left ventricular ejection fraction (LVEF) ≥50%.
Exclusion: Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening; Allergies or contraindications to any of the drugs in the protocol; Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes); Active autoimmune diseases such as SLE, rheumatoid arthritis, etc; Patients with neurological or psychiatric disorders; Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study; The patient is pregnant or breastfeeding; Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.