Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07319793
Eligibility Criteria:
Inclusion Criteria:
* Eligible patients were those who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for myeloid neoplasms (MN), excluding Philadelphia chromosome-positive (Ph+) disease, regardless of age. MN included acute myeloid leukemia (AML) and myelodysplastic syndrome with increased blasts (MDS-IB). Patients were required to have refractory or relapsed disease at the time of transplantation, defined as \>5% blasts in the bone marrow after salvage chemotherapy and prior to the transplant conditioning regimen. Additionally, patients must have achieved minimal residual disease (MRD)-negative remission within 1 month post-transplantation. All participants provided voluntary written informed consent.
Exclusion Criteria:
* Early mortality or relapse within 30 days post-transplantation.
* Active graft-versus-host disease (GVHD) not under control between 30 and 60 days post-transplantation.
* Presence of severe or uncontrolled infections.
* Presence of significant organ dysfunction, defined as:
Hepatic dysfunction: Known severe cirrhosis, portal hypertension, or active liver disease; or laboratory-confirmed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3.0 × the upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.5 × ULN.
Renal dysfunction: Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) or serum creatinine \> 1.5 × ULN; or requirement for regular hemodialysis or peritoneal dialysis.
Cardiac dysfunction: New York Heart Association (NYHA) functional class III or IV; unstable angina, acute myocardial infarction, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 6 months prior to enrollment; left ventricular ejection fraction (LVEF) \< 50% (confirmed by echocardiography or other Doppler examination); clinically significant, uncontrolled arrhythmia.
Respiratory dysfunction: Chronic obstructive pulmonary disease (COPD) or other pulmonary disease requiring long-term oxygen therapy; resting oxygen saturation (SpO₂) \< 92% on room air.
* Participation in another investigational drug trial within the 3 months prior to enrollment.
* Any other condition deemed by the investigator to make the patient unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07319793
Study Brief:
Protocol Section:
NCT07319793