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
- Diseases
- Acute myeloid leukemia
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| People's Liberation Army The General Hospital of Western Theater Command Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Hebei Medical University Second Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Zhengzhou University - First Affiliated Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.