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Not yet recruiting NCT06613035

Twice-per-weekSelinexor, 2 Days Melphalan

Phase III Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selinexor, Melphalan, Intravenous Busulfan, Fludarabine.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • 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

Primary outcome measures

  • 1-year RFS [Time frame: 1-year]
Secondary outcome measures (2)
  • 1-year OS [Time frame: 1-year]
  • 1-year GVHD [Time frame: 1-year]

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:
  • 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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Hebei Medical University Second Hospital — Shijiazhuang
  • Zhengzhou University First Affiliated Hospital — Zhengzhou
  • The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation A — Jinan
  • People's Liberation Army The General Hospital of Western Theater Command — Chengdu

Identifiers

NCT: NCT06613035 · IIT2024062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗