Leukemia Clinical Trial
Official title:
A Phase II Study of LBH589, a Novel Histone Deacetylase Inhibitor, in Relapsed and Refractory Adult Patients With Acute Leukemia (AL) or in Newly Diagnosed Patients Over the Age of 60
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how
well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia
or acute myeloid leukemia.
OBJECTIVES:
Primary
- To determine the antitumor activity of panobinostat, in terms of objective response
rate, time to progression, and survival, in patients with relapsed or refractory acute
lymphoblastic leukemia or acute myeloid leukemia.
- To assess the toxicity of panobinostat in these patients.
Secondary
- To perform correlative laboratory studies to assess changes in various proteins that
may be altered by histone deacetylase inhibition therapy.
OUTLINE: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
Patients undergo peripheral blood and bone marrow sample collection at baseline and on day
28 of course 1 for correlative laboratory studies. Samples are analyzed by RT-PCR for
reactivation of FANCG, FOXO3A, GADD45A, GADD45B, GADD45G, H2AX, and TP73.
After completion of study treatment, patients are followed for at least 4 weeks.
PROJECTED ACCRUAL: A total of 74 patients (37 with acute myeloid leukemia and 37 with acute
lymphoblastic leukemia) will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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