Twice-per-weekSelinexor, 2 Days Melphalan

NCT06613035 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT2024062
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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

Conditions

Acute Myeloid Leukemia

Keywords

allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 1-year RFS

  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.

  1-year

Secondary Outcomes (2)

• 1-year OS

  1-year

• 1-year GVHD

  1-year

Study Arms (2)

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

EXPERIMENTAL

* 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.

Drug: Selinexor; Drug: Melphalan; Drug: Intravenous Busulfan; Drug: Fludarabine

Patients in the BF group will receive the BU3FLU5 conditioning regimen

EXPERIMENTAL

* 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.

Drug: Intravenous Busulfan; Drug: Fludarabine

Interventions

Selinexor DRUG

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

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Melphalan DRUG

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

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Intravenous Busulfan DRUG

3.2 mg/kg on days

Patients in the BF group will receive the BU3FLU5 conditioning regimen; SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Fludarabine DRUG

30 mg/m² on days

Patients in the BF group will receive the BU3FLU5 conditioning regimen; SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia).
• \. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation).
• \. 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.
• \. 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.

You may not qualify if:

• \. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:
• History of uncontrolled or symptomatic angina.
• Myocardial infarction within the last 6 months prior to study enrollment.
• History of arrhythmias requiring medication or with clinically significant symptoms.
• Uncontrolled or symptomatic congestive heart failure (NYHA class \> 2).
• 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).
• \. 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.
• \. 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (4)

Hebei Medical University Second Hospital

Shijiazhuang, Hebeisheng, 05000, China

Location

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, 450000, China

Location

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

Jinan, Shandong, China

Location

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

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

selinexor; Melphalan; fludarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

erlie jiang

CONTACT

15122538106; jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

18622477066; caoyigeng@ams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (4)