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AzTrials

Adult Nasal Type Extranodal NK/T-Cell LymphomaPhase 2NCT01466881

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

A Phase 2 study testing Alisertib, Laboratory Biomarker Analysis and Pharmacological Study in people with Adult Nasal Type Extranodal NK/T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, run by National Cancer Institute (NCI) at 161 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alisertib, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
161 sitesin 2 countries
Study dates
Oct 2011to Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 34Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

161 sites in 2 countries.

161 sites in 2 countries

United States160 sites

  • Oncare Hawaii Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium CCOP

    Ann Arbor, Michigan, 48106

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Mills - Peninsula Hospitals

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Union Hospital of Cecil County

    Elkton MD, Maryland, 21921

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • OnCare Hawaii-Liliha

    Honolulu, Hawaii, 96817-3169

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Oncare Hawaii Inc-Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Allegiance Health

    Jackson, Michigan, 49201

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67901

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • North Shore Hematology Oncology

    Libertyville, Illinois, 60048

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Providence Hospital

    Mobile, Alabama, 36608

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Sutter Cancer Research Consortium

    Novato, California, 94945

  • Ottumwa Regional Health Center

    Ottumwa, Iowa, 52501

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Kansas City CCOP

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of Rochester

    Rochester, New York, 14642

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Metro-Minnesota NCI Community Oncology Research Program

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salem Hospital

    Salem, Oregon, 97301

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Audie L Murphy Veterans Affairs Hospital

    San Antonio, Texas, 78209

  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University Hospital

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94118

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Hematology Oncology Associates of Illinois - Skokie

    Skokie, Illinois, 60076

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • The University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • The University of Arizona Medical Center-University Campus

    Tucson, Arizona, 85724

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
Alisertib, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlisertibDrug

    Also called Aurora A Kinase Inhibitor MLN8237, MLN-8237, MLN8237

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT01466881
Study groupRoleWhat they receive
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.
Receives: Drug: Alisertib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 1 year after registration

Secondary outcomes (3)

  1. Overall Survival (OS)

    Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: Up to 2 years after registration

  2. Progression Free Survival (PFS)

    Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion > 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now > 1.5 cm. Lymph nodes with long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm. PET should be positive if positive PET at baseline.

    Measured: Up to 2 years after registration

  3. To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)

    Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

    Measured: Up to 1 year after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01466881
Sponsor's protocol ID
NCI-2011-03551
Other IDs
NCI-2011-03551, SWOG-S1108, CDR0000714328, S1108, S1108, U10CA180888, U10CA032102
Status last verified
Jan 2015
First submitted
3 Nov 2011
Last updated
10 Mar 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 26077240

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alisertib, Laboratory Biomarker Analysis and Pharmacological Study in people with Adult Nasal Type Extranodal NK/T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, run by National Cancer Institute (NCI) at 161 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (Complete Responses (CR) + Partial Responses (PR)) (time frame: Up to 1 year after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01466881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.

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