Twice-per-weekSelinexor, 2 Days Melphalan

Trial Title: Twice-per-weekSelinexor, 2 Days Melphalan

NCT ID: NCT06613035

Condition: Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Fludarabine
Melphalan
Busulfan

Conditions: Keywords:
allogeneic hematopoietic stem cell transplantation

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Selinexor
Description: Selinexor: 60 mg/day from days -9 to -5.
Arm group label: SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Intervention type: Drug
Intervention name: Melphalan
Description: Selinexor: 60 mg/day from days -9 to -5.
Arm group label: SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Intervention type: Drug
Intervention name: Intravenous Busulfan
Description: 3.2 mg/kg on days
Arm group label: Patients in the BF group will receive the BU3FLU5 conditioning regimen
Arm group label: SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Intervention type: Drug
Intervention name: Fludarabine
Description: 30 mg/m² on days
Arm group label: Patients in the BF group will receive the BU3FLU5 conditioning regimen
Arm group label: SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

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

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 55 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hebei Medical University Second Hospital

Address:
City: Shijiazhuang
Zip: 05000
Country: China

Facility:
Name: Zhengzhou University First Affiliated Hospital

Address:
City: Zhengzhou
Zip: 450000
Country: China

Facility:
Name: The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

Address:
City: Jinan
Country: China

Facility:
Name: People's Liberation Army The General Hospital of Western Theater Command

Address:
City: Chengdu
Zip: 610083
Country: China

Start date: September 30, 2024

Completion date: September 30, 2027

Lead sponsor:
Agency: Institute of Hematology & Blood Diseases Hospital, China
Agency class: Other

Source: Institute of Hematology & Blood Diseases Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06613035