Testing two transplant preparation regimens for older adults with high-risk acute myeloid leukemia
Compares two chemotherapy preparation regimens before stem cell transplant in older adults with leukemia.
Plain-language title generated from the registry record
Registry title: Twice-per-weekSelinexor, 2 Days Melphalan
Key facts
- Where
- Chengdu, Jinan, Shijiazhuang, and Zhengzhou, ChinaSee the 4 sites
- Phase
- Phase 3
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 55 or older with high-risk acute myeloid leukemia who are in complete remission and will have a donor stem cell transplant.
- Age
- 55 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk acute myeloid leukemia (not acute promyelocytic leukemia). The disease must be in complete remission, confirmed by bone marrow test within three days before randomization. High-risk means high-risk by ELN 2022 grading, MRD still positive before transplant, or refractory or relapsed disease.
- Earlier treatment
- People who have already had a stem cell transplant cannot join. The trial is looking for people who will have a donor stem cell transplant (related or unrelated donor).
Main reasons for not taking part
- Previous stem cell transplant
- Active heart disease
- Respiratory failure (PaO2 ≤ 60 mmHg)
- Liver or kidney dysfunction
- Uncontrolled or active infection
Read by machine on 12 November 2026.
Where in China
- People's Liberation Army The General Hospital of Western Theater CommandChengdu, ChinaContact: erlie jiangNo longer taking part
- The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation ArmyJinan, ChinaContact: erlie jiangNo longer taking part
- Hebei Medical University Second HospitalShijiazhuang, ChinaContact: erlie jiangNo longer taking part
- Zhengzhou University - First Affiliated HospitalZhengzhou, ChinaContact: erlie jiangNo 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
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06613035
- Record updated
- 25 September 2024
- Original description
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trialRead full original descriptionShow less
Twice-per-week Selinexor, 2 Days Melphalan Plus BU2FLU3 Compared with BU3FLU5 for Elder High-risk Acute Myeloid Leukemia Undergoing Allogenic Hematopoietic Cell Transplantation: a Multi-center Randomized Phase 3 Trial
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial
Inclusion: 1. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia); Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation); Age ≥ 55 years. 4. Disease status prior to allogeneic transplantation must be complete remission (CRc), confirmed by bone marrow analysis within three days prior to randomization; Karnofsky Performance Score (KPS) of at least 60. 6. Informed consent must be signed prior to the commencement of the study procedures. If the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient; Note: *High-risk AML: ① Patients classified as high-risk according to the ELN 2022 grading criteria. ② AML patients with persistent MRD positivity prior to transplantation. ③ Patients with refractory or relapsed AML.
Exclusion: 1. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:; History of uncontrolled or symptomatic angina; Myocardial infarction within the last 6 months prior to study enrollment; History of arrhythmias requiring medication or with clinically significant symptoms; Uncontrolled or symptomatic congestive heart failure (NYHA class > 2); Ejection fraction below the lower limit of the normal range. 3. Respiratory failure (PaO2 ≤ 60 mmHg). 4. Liver dysfunction (total bilirubin ≥ 3 mg/dL, transaminases > twice the upper limit of normal); Renal dysfunction (creatinine clearance rate < 30 mL/min). 6. Presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements; ECOG performance status of ≥ 4. 8. Uncontrolled or active infection. 9. Any condition that impairs the ability to provide informed consent. 10. Any conditions deemed unsuitable for enrollment by the investigator prior to randomization.