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
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
Phase I will characterize the dose-limiting toxicities (DLTs) and determine the maximum
tolerated dose (MTD) or recommended phase II dose of selinexor when given in combination with
fludarabine and cytarabine.
Selinexor will be given twice weekly (on days 1 and 3) and escalated or de-escalated based on
tolerability. The rolling-6 design will be used for this study. Only cycle 1 of therapy will
be used to evaluate the DLT. Two to six participants can be concurrently enrolled onto a dose
level, dependent on 1) the number of participants enrolled at the current dose level, 2) the
number of participants who have experienced DLT at the current dose level, and 3) the number
of participants entered but with tolerability data pending at the current dose level. Accrual
is suspended when a cohort of six has enrolled or when the study endpoints have been met.
Once the recommended Phase II dose is determined, additional patients will be enrolled, if
necessary, so that at least 6 subjects are treated with the recommended Phase II dose to
determine MTD. After the MTD is determined, 12 additional patients will be treated at this
dose level for further evaluation of tolerability and response.
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