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Clinical Trial Detail

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

Complete title: PANAML: 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

Research Study Number SC-2029
Principal Investigator Todd Cooper
Phase I

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number SC-2029
Contact Todd Cooper
Telephone 206/987-2106

Keywords: Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Pediatric Cancers, Miscellaneous; Myelodysplastic Syndromes (MDS); Leukemia, Myeloid; Preleukemia; Bone Marrow Diseases

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