Spots Global Cancer Trial Database for Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia
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Trial Identification
Brief Title: Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia
Official Title: A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Study ID: NCT03071276
Conditions
Study Description
Brief Summary: 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.
Detailed Description: After the recommended Phase II dose was determined, additional patients began enrolling to receive selinexor at the recommended dose level for further evaluation of tolerability and response. PRIMARY OBJECTIVE: * To estimate the overall response rate, as defined by complete response or complete response with incomplete count recovery, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Jeffrey E. Rubnitz, MD,PhD
Affiliation: St. Jude Children's Research Hospital
Role: PRINCIPAL_INVESTIGATOR
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