A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >66 years .
Recruiting
- Conditions
- Acute Myeloid Leukemia (AML), MDS
- Registration Number
- NL-OMON25024
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
• Patients eligible for standard chemotherapy.
• Patients 66 years and older
Exclusion Criteria
• Acute promyelocytic leukemia
• Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is allowed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Incidence of DLT (part A)<br /><br>• The effect of selinexor on the CR rate (part B of study)
- Secondary Outcome Measures
Name Time Method • Overall survival (time from registration till the death of the patient.)<br /><br>• Event free survival (i.e., time from registration to induction failure (i.e. no CR on induction), death or relapse whichever occurs first)<br /><br>• Disease free survival (time from CR on protocol treatment until relapse or death, whichever comes first)<br /><br>• Prognostic value of molecular markers and gene expression profiles of the leukemia assessed at diagnosis<br /><br>• Prognostic value of minimal residual disease (MRD) measurements following therapy by standardized sampling of marrow/blood