Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
A multicenter, single-arm clinical study of evaluate the efficacy and safety of selinexor combined with venetoclax as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients.
Eligibility criteria
Qualifiers
de novo AML in the ELN2022 high-risk group or MDS in the IPSS-M intermediate-high/high/very-high risk group
Age 18-75 years old, gender is not limited
First hematopoietic stem cell transplant with at least one eligible donor
ECOG physical status score of 0-2
Disqualifiers
bone marrow examination after allo-HSCT suggestive of relapse or measurable residual disease (MRD) before the initiation of maintenance therapy;
Other malignant tumors within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, post-radical thyroid cancer, and post-radical ductal carcinoma in situ;
Current active cardiovascular disease of clinical significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;
Other serious medical conditions that may limit the patient's participation in this trial (e.g., active infection, uncontrolled diabetes);
Trial design
Treatments tested in this trial
- selinexor in combination with venetoclax
Treatment groups
73 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov