Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination With Fludarabine and Cytarabine in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is
controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs
called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block
enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them
to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat
pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS).
The purpose of this study is to test the safety of panobinostat and to find the highest dose
of panobinostat that can be given safely when it is combined with fludarabine and cytarabine.
This pilot study will be done in two parts: The goal of Part 1 of the study is to find the
highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it
is combined with fludarabine and cytarabine. Once that dose is determined, participants will
be enrolled on Part 2: Dose Expansion, to look at the effect of the
panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.
PRIMARY OBJECTIVE:
- Determine a tolerable dose of panobinostat when given in combination with fludarabine
and cytarabine in pediatric patients with relapsed or refractory AML or MDS.
SECONDARY OBJECTIVES:
- Characterize the pharmacokinetics of panobinostat after the first dose and at
steady-state.
- Estimate the overall response rate to the combination of panobinostat, fludarabine, and
cytarabine.
STUDY PART 1: Dose Escalation Cohort
During the dose escalation phase (Part 1), participants will receive one course of
panobinostat plus fludarabine and cytarabine. The starting dose of panobinostat will be 10
mg/m^2/dose, with 2 additional dose levels of 15 and 20, depending on tolerability. Each
course is 12 days
STUDY PART 2: Dose Expansion Cohort
The recommended phase 2 dose (RP2D) will be chosen based on the maximum tolerated dose (MTD)
and the totality of data obtained from study Part 1. Additional patients will be enrolled, if
needed, so that at least 6 patients are treated with the recommended RP2D to confirm the MTD
of panobinostat to be given in study Part 2.
After final MTD determination, 12 additional participants will be treated at this dose level
for further evaluation of tolerability and response, including more complete toxicity data
and estimation of the response rate to the combination of panobinostat, fludarabine, and
cytarabine.
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