Acute Myeloid LeukemiaPhase 2NCT06900088
Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients
A Phase 2 study testing Selinexor in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
- What is being tested?
- Selinexor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:
- Age≥ 16 years old; any gender;
- High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);
- High relapse risk AML, including relapsed refractory AML and patients with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:
- (1)Refractory AML is defined as meeting one of the following conditions
- Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;
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- CR was followed by consolidation and intensive treatment with no recurrence within 12 months;
- It recurred 12 months later, but conventional chemotherapy was ineffective;
- 2 or more relapses;
- Extramedullary leukemia persists. (2)Relapsed AML i.e., re-initialization of leukemic cells in the peripheral blood after complete remission (CR) or bone marrow primitive cells >0.050 (except for other reasons such as bone marrow reconstitution after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.
- (3)Positive pre-transplant MRD, i.e., one of the following conditions is met:
- Proportion of abnormal myeloid cells >0.01% by pre-transplant flow assay;
- Positive pre-transplantation molecular biology-related tests. (4)AML with poor prognosis (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) 2023 Edition) 4.Meets WHO diagnostic criteria for staging CMML; 5.MDS or CMML transforms AML.
Who cannot join
- Patients with any of the following are not eligible for enrollment in this study:
- Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.
- Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);
- Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;
- Patients who are pregnant or who are unable to use appropriate contraception during treatment;
- Suspected hypersensitivity to the experimental drug or any of its excipients;
- Active heart disease, defined as one or more of the following:
- （1）History of uncontrolled or symptomatic angina; （2）Myocardial infarction less than 6 months from study entry; （3）History of tardive dyskinesia requiring medication or clinically significant symptoms; （4）Uncontrolled or symptomatic congestive heart failure (> NYHA class 2) （5）Ejection fraction is below the lower limit of the normal range. 7. Those deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Tianjin
About this study
Official title: Efficacy and Safety of Selinexor Combined With Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Explorato
Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study
Read the detailed description
Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)
- Being tested
- Selinexor
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation
| Study group | Role | What they receive |
|---|---|---|
| patients with high-risk myeloid neoplasms after transplantation | Experimental | maintenance therapy with Selinexor combined with Azacitidine Receives: Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence free survival rate (RFS)
the rate at which a patient has been on the drug for at least 1 year without morphological relapse or death of the subject from the transplantation date (whichever comes first)
Measured: 2 years
Secondary outcomes (4)
2-year non-relapse mortality rate (NRM)
incidence of death from causes other than AML relapse/progression from the date of transplantation to the date of the subject's death
Measured: 2 years
2-year survival rate (OS)
the 2-year survival rate from transplantation to death from any causes
Measured: 2 years
Median overall survival (OS)
The time from transplantation to death from any causes
Measured: 2 years
Cumulative incidence of acute graft-versus-host disease (GVHD)
Cumulative incidence of grade II-IV acute GVHD at 6 months after enrollment. Acute GVHD will be graded based on the diagnostic and severity scores used by the Blood and Bone Marrow Transplantation Clinical Trial Network (BMTCTN).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start25 Apr 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900088
- Sponsor's protocol ID
- IIT2024099
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No