Twice-per-weekSelinexor, 2 Days Melphalan

September 22, 2024 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Zhengzhou University First Affiliated Hospital
    • Shandong
      • Jinan, Shandong, China
        • The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • People's Liberation Army The General Hospital of Western Theater Command
    • hebeisheng
      • Shijiazhuang, hebeisheng, China, 05000
        • Hebei Medical University Second Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Selinexor
Selinexor: 60 mg/day from days -9 to -5.
Drug: Melphalan
Selinexor: 60 mg/day from days -9 to -5.
Drug: Intravenous Busulfan
3.2 mg/kg on days
Drug: Fludarabine
30 mg/m² on days
Experimental: 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.
Drug: Intravenous Busulfan
3.2 mg/kg on days
Drug: Fludarabine
30 mg/m² on days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year RFS
Time Frame: 1-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.
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year OS
Time Frame: 1-year
1-year OS
1-year
1-year GVHD
Time Frame: 1-year
1-year GVHD
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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