Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma
This phase II trial studies how well alisertib works in treating patients with peripheral T-cell non-Hodgkin lymphoma that has come back after a period of improvement or has not responded to treatment. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate (complete responses + partial responses) after
treatment with alisertib (MLN8237) in patients with relapsed or refractory peripheral T-cell
non-Hodgkin lymphoma.
II. To assess overall survival (OS) and progression-free survival (PFS) in this patient
population.
III. To evaluate the safety and tolerability of MLN8237 treatment for this patient
population.
IV. To explore the association between pre-treatment aurora kinase A expression in tumor
biopsies as measured by fluorescence in situ hybridization (FISH) and objective response
rate in patients with peripheral T-cell lymphomas (PTCL) treated with MLN8237.
IV. To investigate the copy number, mutational status, expression of aurora kinase (A, B,
and C) and associated signaling pathways in PTCL utilizing tissue microarray analysis (TMA)
before and after treatment with MLN8237.
V. To investigate changes in the serum cytokine profile pre- and post- aurora kinase
Inhibitor treatment.
VI. To evaluate serum markers of apoptosis pre- and post- aurora kinase inhibitor treatment
as pharmacodynamic markers of efficacy.
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Treatment repeats
every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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