Clinical trial · Interventional
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
Phase I Study to Assess the Tolerability and Efficacy of Selinexor (KPT-330) as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With AML and High Risk MDS After Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial studies the side effects and best dose of selinexor when given after stem cell transplant in treating patients with acute myeloid leukemia that is at intermediate or high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.
Conditions
Conditions (5)
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| de Novo Myelodysplastic Syndrome | De Novo Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Secondary Myelodysplastic Syndrome | Secondary Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (selinexor)
- description
- Beginning on day 60-100 after allo-SCT without evidence of GVHD above grade 1 and disease relapse with stable hematopoietic recovery, patients receive selinexor PO on day 1 of each week or on days 1 and 3 of weeks 1-3. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Selinexor
Primary outcomes (1)
- measure
- MTD of selinexor, determined according to incidence of DLT as graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- timeFrame
- Up to 29 days
Secondary outcomes (7)
- measure
- Incidence of acute GVHD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Signed, written informed consent in accordance with federal, local, and institutional guidelines * Patients underwent allo-SCT with intermediate risk and high risk AML and high risk MDS (defined by American Society for Blood and Marrow Transplantation \[ASBMT\] criteria), who are within 60 to 100 days after allo-SCT * There is no evidence of disease relapse at the time of screening, and minimal residual disease (MRD) is acceptable * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Absolute neutrophil count (ANC) \> 1000 uL * Platelets \>= 20,000 without platelet transfusion * Creatinine clearance \> 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measured * Total bilirubin =\< 2 mg/dl unless high indirect bilirubin is due to a congenital disorder * Transaminases (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) =\< 2.0 x upper limit of normal (ULN) * Prothrombin time (PT) and partial thromboplastin time (PTT) =\< 2 x ULN * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures * It is important patients understand the need to use birth control while on this study; female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening (\< 3 days prior to first dose), male patients with partners of childbearing potential must agree to use effective contraception during the study period and a period of 3 months after the last dose of study drug; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose Exclusion Criteria: * Patients with acute GVHD grade II-IV * Treatment with any investigational agent within three weeks prior to first dose in this study * Major surgery within 2 weeks of first dose of study drug; patients must have recovered from the effects of any surgery performed greater than 2 weeks previously * Patient has a concurrent active malignancy under treatment * Unstable cardiovascular function: * Symptomatic ischemia, or * Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or * Congestive heart failure (CHF) NYHA class \>= 3, or * Myocardial infarction (MI) within 3 months * Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable * Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen) * Known human immunodeficiency virus (HIV) infection * Any medical condition which, in the investigator's opinion, could compromise the patient's safety * Patients unable to swallow tablets or patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function
References
Publications (0)
Data not yet available