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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01466881

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2011-10-01

Expected to finish

2015-03-01

Last updated by the study team

2016-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• The University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• The University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• Oncare Hawaii Inc-POB II — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• OnCare Hawaii-Liliha — Honolulu, Hawaii, United States
• Kuakini Medical Center — Honolulu, Hawaii, United States
• Oncare Hawaii Inc-Kuakini — Honolulu, Hawaii, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Castle Medical Center — Kailua, Hawaii, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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