Clinical trial NCT06613035: Twice-per-weekSelinexor, 2 Days Melphalan
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: allogeneic hematopoietic stem cell transplantation
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 126
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 1-year RFS
timeFrame: 1-year
Secondary outcomes:
measure: 1-year OS
timeFrame: 1-year
measure: 1-year GVHD
timeFrame: 1-year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Second Hospital
state: hebeisheng
city: Zhengzhou
country: China
facility: Zhengzhou University First Affiliated Hospital
state: Henan
city: Jinan
country: China
facility: The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
state: Shandong
city: Chengdu
country: China
facility: People's Liberation Army The General Hospital of Western Theater Command
state: Sichuan
Study officials:
References: