Clinical trialNCT03071276TerminatedPhase 2Interventional

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

SponsorSt. Jude Children's Research HospitalEnrollment37Acute Myeloid Leukemia (AML)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined with fludarabine and cytarabine. The Phase II portion of the protocol is reflected in this registration. The goal of the Phase II portion of this protocol is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with acute myeloid leukemia (AML). The investigators will examine the effect of this combination treatment.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jeffrey E. Rubnitz, MD,PhD
St. Jude Children's Research Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Phoenix Children'S Hospital
Phoenix, Arizona, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
University of Chicago
Chicago, Illinois, United States
Children'S Hospital of Michigan
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, United States
Cook Children'S Medical Center
Fort Worth, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CytarabineFludarabineSelinexorMethotrexate

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 14 Jan 2016
Primary completion: 30 Apr 2019
Completion: 30 Apr 2019
Last update posted: 22 May 2020
Registered enrollment: 37
Registry id: NCT03071276

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.