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
- 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.
- 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
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
Hematological response rate (morphologic complete response or partial response)
1 year after completion of treament
Leslie Popplewell, MD
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|South Pasadena Cancer Center||South Pasadena, California 91030|