Non Hodgkin Lymphoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT01466881

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 132 Locations for this study

See Locations Near You

Providence Hospital
Mobile Alabama, 36608, United States
The University of Arizona Cancer Center-Orange Grove Campus
Tucson Arizona, 85704, United States
The University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States
The University of Arizona Medical Center-University Campus
Tucson Arizona, 85724, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley California, 94704, United States
Mills - Peninsula Hospitals
Burlingame California, 94010, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Sutter Cancer Research Consortium
Novato California, 94945, United States
California Pacific Medical Center-Pacific Campus
San Francisco California, 94118, United States
Sutter Pacific Medical Foundation
Santa Rosa California, 95403, United States
Sutter Solano Medical Center/Cancer Center
Vallejo California, 94589, United States
Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Emory University/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Oncare Hawaii Inc-Pali Momi
Aiea Hawaii, 96701, United States
Pali Momi Medical Center
Aiea Hawaii, 96701, United States
Oncare Hawaii Inc-POB II
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
OnCare Hawaii-Liliha
Honolulu Hawaii, 96817, United States
Kuakini Medical Center
Honolulu Hawaii, 96817, United States
Oncare Hawaii Inc-Kuakini
Honolulu Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Castle Medical Center
Kailua Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Northwestern University
Chicago Illinois, 60611, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park Illinois, 60035, United States
Presence Saint Mary's Hospital
Kankakee Illinois, 60901, United States
North Shore Hematology Oncology
Libertyville Illinois, 60048, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Illinois Cancer Specialists-Niles
Niles Illinois, 60714, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie Illinois, 60076, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames Iowa, 50010, United States
Ottumwa Regional Health Center
Ottumwa Iowa, 52501, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67901, United States
Cancer Center of Kansas - McPherson
McPherson Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Kansas City CCOP
Prairie Village Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wichita CCOP
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Hematology/Oncology Clinic LLP
Baton Rouge Louisiana, 70809, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport Louisiana, 71103, United States
Union Hospital of Cecil County
Elkton MD Maryland, 21921, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor Michigan, 48106, United States
Oakwood Hospital and Medical Center
Dearborn Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Genesys Regional Medical Center
Grand Blanc Michigan, 48439, United States
Allegiance Health
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Metro-Minnesota NCI Community Oncology Research Program
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Saint Luke's Cancer Institute
Kansas City Missouri, 64111, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Joseph Health Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph Missouri, 64507, United States
Saint Louis University Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cancer Research for the Ozarks NCORP
Springfield Missouri, 65804, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Montana Cancer Consortium CCOP
Billings Montana, 59101, United States
Saint Vincent Healthcare
Billings Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings Montana, 59102, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Glacier Oncology PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula Montana, 59802, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Weill Medical College of Cornell University
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
Iredell Memorial Hospital
Statesville North Carolina, 28677, United States
Mid Dakota Clinic
Bismarck North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Salem Hospital
Salem Oregon, 97301, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Roper Hospital
Charleston South Carolina, 29401, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio Texas, 78209, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio Texas, 78229, United States
University Hospital
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
UW Cancer Center Johnson Creek
Johnson Creek Wisconsin, 53038, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT01466881

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider