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Clinical Trials in China / NCT06613035
Starting soon Phase 3

Twice-per-weekSelinexor, 2 Days Melphalan

NCT06613035 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 3
Started
2024-09-30
Last updated
2024-09-25

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

SelinexorMelphalanIntravenous BusulfanFludarabine

Selinexor: Selinexor: 60 mg/day from days -9 to -5.

Melphalan: Selinexor: 60 mg/day from days -9 to -5.

Intravenous Busulfan: 3.2 mg/kg on days

Fludarabine: 30 mg/m² on days

Study 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

Eligibility

Sex
ALL
Min age
55 Years
Max age
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Hebei Medical University Second Hospital Shijiazhuang Hebeisheng
Zhengzhou University First Affiliated Hospital Zhengzhou Henan
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Jinan Shandong
People's Liberation Army The General Hospital of Western Theater Command Chengdu Sichuan

More Institute of Hematology & Blood Diseases Hospital, China trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06613035 on ClinicalTrials.gov ↗ ← All trials in China