Home
Clinical Trials
Alisertib in Treating Patient...

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

Last Updated: 2016-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma

NCT01567709

Adult B Acute Lymphoblastic Leukemia Adult T Acute Lymphoblastic Leukemia Anaplastic Large Cell Lymphoma +32 more

COMPLETED PHASE1

Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

NCT00807495

Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma Burkitt's Lymphoma +2 more

COMPLETED PHASE2

Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

NCT01812005

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma +8 more

TERMINATED PHASE2

MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine

NCT01397825

Diffuse Large B-Cell Lymphoma Transformed Follicular Lymphoma Mantle Cell Lymphoma +1 more

COMPLETED PHASE1/PHASE2

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

NCT01482962

Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Alisertib

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Pharmacological Study

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alisertib

Given PO

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Pharmacological Study

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aurora A Kinase Inhibitor MLN8237 MLN-8237 MLN8237

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have histologically or cytologically confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) having progressed after a minimum of one systemic therapy with any of the following T-cell histologies:

* Peripheral T-cell NHL (PTCL) not otherwise specified (NOS)
* Anaplastic large cell T-cell lymphoma (ALCL) that is anaplastic lymphoma kinase either positive or negative
* Angioimmunoblastic T-cell NHL
* Subcutaneous panniculitis-like T-cell lymphoma
* Enteropathy-associated T-cell NHL
* Hepatosplenic T-cell lymphomas
* Extranodal natural killer (NK)/T-cell lymphoma, nasal type
* Adult T-cell leukemia/lymphoma
* Unclassifiable PTCL
* Transformed cutaneous T-cell lymphoma (CTCL) to PTCL with systemic involvement (not local skin transformation)
* No other histologies are eligible; examples of ineligible histologies include: T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, NK-cell leukemia, mycosis fungoides, Sezary syndrome, lymphomatoid papulosis, and primary CTCL
* Patients must have received at least one course of prior systemic therapy which may include chemotherapy, antibody therapy, or immunotherapy; for all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must not be within 84 days of radioimmunotherapy; steroids at a low dose for control of itching (up to the equivalent of 20 mg of prednisone daily) are allowed
* Patients may have received prior radiation in combination with systemic therapy; patients must not be within 21 days of external beam radiation therapy
* Patients must not have received a previous allogeneic stem cell transplant or be within 90 days of an autologous stem cell transplant
* Adequate sections and a paraffin block from the relapsed/refractory specimen must be submitted for review by the lymphoma pathology group; an adequate biopsy requires sufficient tissue to establish the architecture and a Revised European American Lymphoma (REAL) or World Health Organization (WHO) histologic subtype with certainty; thus, core biopsies, especially multiple core biopsies MAY be adequate; whereas, needle aspirations or cytologies are not adequate
* Patients must have bidimensionally measurable disease within 28 days prior to registration; a diagnostic quality computed tomography (CT) scan of the chest abdomen, pelvis, neck and positron emission tomography (PET)/CT must be performed within 28 days of registration (PET/CT scan can be done instead of separate PET and CT scans only if the CT component is a diagnostic CT with contrast); patients who also have non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
* Patients must have a bilateral or unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
* Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory tests that are performed to assess clinical signs of central nervous system involvement must have been performed within 42 days prior to registration, and the results must be negative
* Patients must be able to swallow tablets
* Patients known to be human immunodeficiency virus (HIV)-positive must not have multi-drug resistant HIV infection, CD4 counts \< 150/mcL, or other concurrent acquired immunodeficiency syndrome (AIDS)-defining conditions
* Patients must be offered the opportunity to consent to the banking of specimens for future use
* Absolute granulocyte count \>= 1,500 cells/mcL; patients with documented marrow involvement may be transfused to this value
* Platelet count \>= 75,000 cells/mcL; patients with documented marrow involvement may be transfused to this value
* Serum creatinine (mg/dL) =\< institutional upper limit of normal (IULN) obtained within 14 days prior to registration
* Calculated creatinine clearance \> 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
* Serum bilirubin =\< 2 times institutional upper limit of normal
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =\< 2.5 x IULN
* Serum lactate dehydrogenase (LDH) obtained within 14 days prior to registration
* Patients must have a Zubrod performance status of 0, 1, or 2
* Patients must NOT have New York Heart Association (NYHA) class II-IV heart failure
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
* Pregnant or nursing women are not eligible; women/men of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 4 months after completion of MLN8237 administration; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Barr

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Providence Hospital

Mobile, Alabama, United States

Site Status

The University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Site Status

The University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status

The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Mills - Peninsula Hospitals

Burlingame, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Sutter Cancer Research Consortium

Novato, California, United States

Site Status

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status