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Pyrimidine Analog
Selinexor for Leukemia
Phase 1
Waitlist Available
Led By Kendra Sweet, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Potential participants must have newly diagnosed, previously untreated acute myeloid leukemia (AML) (excluding M3); Must have adverse-risk AML defined as poor-risk karyotype (complex, monosomal or other known poor risk cytogenetic abnormality), poor-risk mutations/fusion genes or known history of antecedent hematologic disorder, or treatment related AML, or be ≥60 years of age; Cytogenetics, FISH or mutational analysis confirming adverse risk features must have been done within 90 days prior to enrollment.
May not have undergone any prior therapy for their AML other than hydroxyurea. However, if patients had an antecedent myelodysplastic syndrome (MDS), prior treatment with a hypomethylating agent or any other therapy (with the exception of allogeneic stem cell transplant) used to treat their MDS is allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial is testing if it's safe to combine selinexor with daunorubicin and cytarabine, and what the maximal tolerated dose is.
Eligible Conditions
- Leukemia
- Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal Tolerated Dose (MTD) of Selinexor
Secondary outcome measures
Disease Free Survival (DFS)
Overall Survival (OS)
Rate of Complete Response (CR) Plus Complete Response with Incomplete Count Recovery (CRi).
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation - SelinexorExperimental Treatment3 Interventions
Dose escalation of selinexor with fixed doses of daunorubicin and cytarabine.
Induction Therapy may be followed by Consolidation Phase and Maintenance Phase as outlined in the Detailed Description and Intervention Descriptions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Cytarabine
2016
Completed Phase 3
~3310
Daunorubicin
2013
Completed Phase 4
~4940
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,414 Total Patients Enrolled
41 Trials studying Leukemia
2,002 Patients Enrolled for Leukemia
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,558 Total Patients Enrolled
12 Trials studying Leukemia
652 Patients Enrolled for Leukemia
Kendra Sweet, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
62 Total Patients Enrolled
2 Trials studying Leukemia
62 Patients Enrolled for Leukemia
Frequently Asked Questions
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