Clinical trial · Interventional
Twice-per-weekSelinexor, 2 Days Melphalan
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
NCT06613035CI-TRIAL-00081014not yet recruitingPhase 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)
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
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Intravenous Busulfan | Drug | Busulfan | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen
- description
- * Selinexor: 60 mg/day from days -9 to -5. * Melphalan: 60 mg/m² on days -8 and -7. * Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5. * Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.
- interventionNames
- Drug: Selinexor
- Drug: Melphalan
- Drug: Intravenous Busulfan
- Drug: Fludarabine
- type
- EXPERIMENTAL
- label
- Patients in the BF group will receive the BU3FLU5 conditioning regimen
- description
- * Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7. * Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2.
- interventionNames
- Drug: Intravenous Busulfan
- Drug: Fludarabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia). 2\. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation). 3\. 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. 5\. 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 Criteria: * 1\. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following: 1. History of uncontrolled or symptomatic angina. 2. Myocardial infarction within the last 6 months prior to study enrollment. 3. History of arrhythmias requiring medication or with clinically significant symptoms. 4. Uncontrolled or symptomatic congestive heart failure (NYHA class \> 2). 5. 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). 5\. 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. 7\. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.