Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02676323

Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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) ormyelodysplastic 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.
Status: 
Recruiting
Study Date: 
Mon, 02/01/2016 to Sun, 04/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Panobinostat Panobinostat will be given orally (PO) on days 1, 3, 5, 8, 10, and 12. Other Name: LBH589 Drug: Fludarabine Fludarabine will be given intravenously (IV), 30 mg/m^2/dose over 30 minutes, daily for 5 days (days 8-12). Other Names: Fludara® Fludarabine phosphate 2-fluoro-ara-AMP Drug: Cytarabine Cytarabine will be given IV, 2 gram/m^2/dose over 4 hours, daily for 5 days (days 8-12). Other Names: Cytosine arabinoside Ara-C Cytosar® Drug: Intrathecal Triples Given intrathecally (IT). Other Names: ITMHA methotrexate/hydrocortisone/cytarabine 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. Other Names: Leucovorin calcium Leucovorin rescue