Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the safety of selinexor (KPT-330) and to find the
highest dose of selinexor (KPT-330) that can be given safely when it is combined with two
chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase
I and Phase II.
The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can
give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine.
The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) 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 leukemia or MDS. The investigators will
examine the effect of this combination treatment.
PRIMARY OBJECTIVE:
- Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric
patients with relapsed or refractory hematologic malignancies included acute myeloid
leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia
(MPAL) and myelodysplastic syndrome (MDS).
SECONDARY OBJECTIVES:
- To characterize the pharmacokinetics of selinexor, when administered in tablet form,
after the first dose and at steady-state, as well as in combination with fludarabine and
cytarabine
- To estimate the overall response rate of selinexor given with fludarabine and cytarabine
in patients with relapsed or refractory hematologic malignancies