Alisertib in Treating Patients With 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.
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
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma|
- Overall response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Association between pre-treatment Aurora kinase A expression levels and overall response will be explored.
- Aurora kinase A expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]Baseline expression levels of Aurora kinase A will be quantitated, ranked, and analyzed for association with overall response using univariate logistic regression.
- OS [ Time Frame: From date of registration to date of death due to any cause, assessed at 1 year ] [ Designated as safety issue: No ]Analyses will explore associations with Aurora kinase A expression levels using univariate Cox regression.
- PFS [ Time Frame: From date of registration to date of first observation of progressive disease or death due to any cause, assessed at 1 year ] [ Designated as safety issue: No ]Analyses will explore associations with Aurora kinase A expression levels using univariate Cox regression.
- Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Analyses will explore associations with Aurora kinase A expression levels.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Pharmacological Study
Other Name: pharmacological studiesOther: Laboratory Biomarker Analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466881
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|Principal Investigator:||Paul Barr||Southwest Oncology Group|