NCT01466881

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Nasal Type Extranodal NK/T-Cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-Cell Lymphoma
• Hepatosplenic T-Cell Lymphoma
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Recurrent Adult Non-Hodgkin Lymphoma
• Recurrent Adult T-Cell Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	Alisertib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2011-11-08
• Last updated: 2016-03-10
• Results posted: 2016-03-10

Locations

161 sites across 2 countries: United States, Canada