Protocol

SELHEM: A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination with Fludarabine and Cytarabine in Pediatric Patients with Refractory Leukemia or Myelodysplastic Syndrome

Diseases

Leukemias / Lymphomas : Relapsed or refractory leukemia or hematologic malignancies


Description

The purpose of this study is to test how safe and effective selinexor (KPT-330) is and to find the highest dose of selinexor that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). The study drug, selinexor (KPT-330), is experimental. This means that it has not yet been approved by the U.S. Food and Drug Administration.

This study will be done in two parts: Phase I and Phase II. The Phase I part of the study will find the highest tolerable dose of selinexor that can be given to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. Once that dose is determined, patients will enroll on the Phase II portion of the trial to look at the effect of the selinexor/fludarabine/cytarabine combination in patients with leukemia or MDS.


Objectives


Eligibility criteria, among others, include:

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact

Jeffery E. Rubnitz, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.