Twice-per-weekSelinexor, 2 Days Melphalan

NCT ID: NCT06613035

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-09-30

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

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

• 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.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

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

Melphalan

Intervention Type: DRUG

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

Intravenous Busulfan

Intervention Type: DRUG

3.2 mg/kg on days

Fludarabine

Intervention Type: DRUG

30 mg/m² on days

Patients in the BF group will receive the BU3FLU5 conditioning regimen

• 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.

Group Type: EXPERIMENTAL

Intravenous Busulfan

Intervention Type: DRUG

3.2 mg/kg on days

Fludarabine

Intervention Type: DRUG

30 mg/m² on days

Interventions

Selinexor

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

Intervention Type: DRUG

Melphalan

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

Intervention Type: DRUG

Intravenous Busulfan

3.2 mg/kg on days

Intervention Type: DRUG

Fludarabine

30 mg/m² on days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebei Medical University Second Hospital

Shijiazhuang, Hebeisheng, China

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, 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

Countries

China

Central Contacts

erlie jiang

Role: CONTACT

jiangerlie@ihcams.ac.cn

15122538106

yigeng cao

Role: CONTACT

caoyigeng@ams.ac.cn

18622477066

Other Identifiers

IIT2024062

Identifier Type: -

Identifier Source: org_study_id