Fact CheckerSign in

NCT06613035Not yet recruitingPhase 3

Twice-per-weekSelinexor, 2 Days Melphalan

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
126 (estimated)
First submitted
22 Sept 2024
Start date
30 Sept 2024
Primary completion date
30 Sept 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT06613035

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 126
  • From 30 Sept 2024 to the primary completion date, 30 Sept 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
People's Liberation Army The General Hospital of Western Theater Command
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Hebei Medical University Second Hospital
Coordinator of this site? Confirm its status
ShijiazhuangChinaUnknown status
Zhengzhou University - First Affiliated Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.