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
6 other identifiers
interventional
42
2 countries
161
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2011
Typical duration for phase_2
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
March 10, 2016
CompletedMarch 10, 2016
January 1, 2015
3.2 years
November 3, 2011
February 9, 2016
February 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))
Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Up to 1 year after registration
Secondary Outcomes (3)
Overall Survival (OS)
Up to 2 years after registration
Progression Free Survival (PFS)
Up to 2 years after registration
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)
Up to 1 year after registration
Other Outcomes (1)
Aurora Kinase A Expression
Baseline
Study Arms (1)
Treatment (alisertib)
EXPERIMENTALPatients 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.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (161)
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 D.C., District of Columbia, 20007, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, 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, 96817-3169, 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
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, 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, 48106-0995, 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
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
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, 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 4E6, Canada
Related Publications (1)
Barr PM, Li H, Spier C, Mahadevan D, LeBlanc M, Ul Haq M, Huber BD, Flowers CR, Wagner-Johnston ND, Horwitz SM, Fisher RI, Cheson BD, Smith SM, Kahl BS, Bartlett NL, Friedberg JW. Phase II Intergroup Trial of Alisertib in Relapsed and Refractory Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides: SWOG 1108. J Clin Oncol. 2015 Jul 20;33(21):2399-404. doi: 10.1200/JCO.2014.60.6327. Epub 2015 Jun 15.
PMID: 26077240DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lymphoma Committee Statistician
- Organization
- SWOG Statistical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Barr
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 8, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
March 10, 2016
Results First Posted
March 10, 2016
Record last verified: 2015-01