Acute Myeloid Leukemia
Conditions
Keywords
allogeneic hematopoietic stem cell transplantation
Brief summary
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
Detailed 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 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT. Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
Interventions
DRUGSelinexor
Selinexor: 60 mg/day from days -9 to -5.
DRUGMelphalan
Selinexor: 60 mg/day from days -9 to -5.
3.2 mg/kg on days
DRUGFludarabine
30 mg/m² on days
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year RFS | 1-year | The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year OS | 1-year | 1-year OS |
| 1-year GVHD | 1-year | 1-year GVHD |
Countries
China
Contacts
Primary Contacterlie jiang
Backup Contactyigeng cao
Outcome results
None listed