Acute Myeloid Leukemia (AML) Clinical Trial
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
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.
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.
;
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