Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia
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.
Timeline
- Start
- 2016-01-14
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
Outcome
Outcome not reported
Stopped (Enrollment): “Due to slow enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | — | Oral |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Methotrexate | Small molecule | — | Intrathecal |