Twice-per-weekSelinexor, 2 Days Melphalan

Registration Number
NCT06613035
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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 CR...

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
126
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.

    4. 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.

Read More
Exclusion Criteria
    1. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:

    2. History of uncontrolled or symptomatic angina.

    3. Myocardial infarction within the last 6 months prior to study enrollment.

    4. History of arrhythmias requiring medication or with clinically significant symptoms.

    5. Uncontrolled or symptomatic congestive heart failure (NYHA class > 2).

    6. 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).

    7. 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.

    8. 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.

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimenSelinexor* 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.
SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimenIntravenous Busulfan* 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.
Patients in the BF group will receive the BU3FLU5 conditioning regimenIntravenous Busulfan* 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.
SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimenMelphalan* 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.
SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimenFludarabine* 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.
Patients in the BF group will receive the BU3FLU5 conditioning regimenFludarabine* 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.
Primary Outcome Measures
NameTimeMethod
1-year RFS1-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 Outcome Measures
NameTimeMethod
1-year OS1-year

1-year OS

1-year GVHD1-year

1-year GVHD

Trial Locations

Locations (4)

Zhengzhou University First Affiliated Hospital

🇨🇳

Zhengzhou, Henan, China

Hebei Medical University Second Hospital

🇨🇳

Shijiazhuang, hebeisheng, China

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

🇨🇳

Jinan, Shandong, China

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

🇨🇳

Chengdu, Sichuan, China

© Copyright 2024. All Rights Reserved by MedPath