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Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT02676323 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-11-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Panobinostat

Panobinostat will be given orally (PO) on days 1, 3, 5, 8, 10, and 12.

DRUG

Fludarabine

Fludarabine will be given intravenously (IV), 30 mg/m\^2/dose over 30 minutes, daily for 5 days (days 8-12).

DRUG

Cytarabine

Cytarabine will be given IV, 2 gram/m\^2/dose over 4 hours, daily for 5 days (days 8-12).

DRUG

Intrathecal Triples

Given intrathecally (IT).

DRUG

Leucovorin

Leucovorin (5 mg/m\^2/dose, max 5 mg) may be given PO or IV at 24 and 30 hours after each ITMHA.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey E. Rubnitz, MD,PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-03
Primary Completion
2018-04-09
Completion
2018-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676323 on ClinicalTrials.gov