Clinical trial · Interventional
Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy
An Exploratory Clinical Study of Selinexor Combined With Venetoclax and Azactidine in the Treatment of Acute Myeloid Leukemia Patients Who Are Not Eligible for Intense Chemotherapy Regimen at Initial Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The number of participants in the study did not meet expectations
Summary
Brief summary (as posted)
This study is a single arm open exploratory clinical trial to evaluate the efficacy and safety of selinexor combined with venetoclax and azacitidine. This study will be divided into two stages: dose increasing stage and dose expanding stage. In the dose-increasing stage, the study induction therapy was designed using a 3+3 design. The induction therapy and consolidation therapy of the subjects will be administered at RP2D doses. During this study period, there were a total of 4 cycles. The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy. In addition, if the subject does not achieve remission (CR/Cr or PR) after 2 cycles of consolidation treatment (at the end of the 4th course), the study will be terminated by the subject, and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Selinexor | Drug | Selinexor | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- selinexor venetoclax Azacitidine
- description
- In the dose-increasing stage, the subject induction therapy was designed using a 3+3 design. selinexor 60mg QW, 40mg BIW, or 60mg BIW, in combination with venetoclax 100mg d1 200mg d2 400mg d3-28, orally once a day, and azacitidine 75mg/m2, d1-7, subcutaneously. The medication regimen was repeated every 28 days. In this case, RP2D is determined based on MTD, safety, and all other data. During this study period, there were a total of 4 courses. The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy.
- interventionNames
- Drug: Selinexor
- Drug: Venetoclax
- Drug: Azacitidine
Primary outcomes (1)
- measure
- RP2D of selinexor in this study
- timeFrame
- 1 year
- description
- from the first day to the last day of the cycle
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed AML patients diagnosed according to WHO standards who are not suitable for the standard induction treatment regimen of cytarabine combined with anthracycline drugs due to age or comorbidities. 2. Age ≥ 75 years old, ECOG score 0-2 points; The patient's age range is 18-75 years old, with an ECOG score of 0-3. 3. Liver function meets the following criteria: total bilirubin\<3 × Upper limit of normal range (ULN) (\<75 years old), total bilirubin\<1.5 × ULN (≥ 75 years old), AST\<3 × ULN and ALT\<3 × ULN. 4. Renal function meets the following criteria: creatinine clearance rate ≥ 30 mL/min (Cockroft-Gault formula). 5. Expected survival time greater than 6 months Exclusion Criteria: 1. patient who has received BCL2 inhibitors, demethylation drugs, chemotherapy, CAR-T therapy, or other experimental therapies. 2. History of myeloproliferative tumors (MPN). 3. Cytogenetic low risk, such as t (8; 21), inv (16), t (16; 16) or t (15; 17). 4. Acute promyelocytic leukemia. 5. AML central nervous system (CNS) involvement. 6. Pregnancy or lactation period. 7. I underwent major surgery within 4 weeks before the first study medication. 8. Subjects with unstable or active cardiovascular diseases who meet any of the following criteria: 9. Symptomatic myocardial ischemia;
References
Publications (0)
Data not yet available