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Phase 2 N=42 Treatment

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

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

Enrolled (actual)
42
Serious AEs
51.3%
Results posted
Mar 2016
Primary outcome: Primary: Objective Response Rate (Complete Responses (CR) + Partial Responses (PR)) — 2; 7; 28 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Alisertib (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))
2; 7; 28
SECONDARY
Overall Survival (OS)
8
SECONDARY
Progression Free Survival (PFS)
3
SECONDARY
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)
1; 2; 12; 1; 1; 1

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.

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 = 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) = 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 pe
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01466881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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