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Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00807495
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Brief Summary:
This is an open-label, multicenter, phase 2 study of alisertib a/k/a MLN8237 in patients with relapsed or refractory non-hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma Burkitt's Lymphoma Precursor B-lymphoblastic Leukemia/Lymphoma T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component Drug: MLN8237 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma
Study Start Date : February 2009
Primary Completion Date : January 2011
Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: 1
Drug: MLN8237
MLN8237 will be administered orally at a dose of 50 mg twice daily for seven consecutive days followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable treatment-related toxicity

Primary Outcome Measures :
  1. Response rate: partial plus complete [ Time Frame: CT scans of neck, chest, abdomen, pelvis, and PET scan are performed during screening and repeated, up to 12 months. Bone marrow aspiration and biopsy are performed during screening and to confirm CR if appropriate. ]

Secondary Outcome Measures :
  1. Time to progression, progression free survival, and duration of response. [ Time Frame: Imaging performed serially to 12 months. Bone marrow performed during screening and repeated to confirm complete response if appropriate. ]
  2. Safety, tolerability based on vital signs, physical examination, laboratory tests, adverse events [ Time Frame: Through 30 days after last dose. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  1. Patients must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy:

    • Diffuse large B-cell lymphoma
    • Mantle cell lymphoma
    • Burkitt's lymphoma
    • Precursor B-lymphoblastic leukemia/lymphoma
    • T-cell lymphoma, excluding primary cutaneous T-cell lymphoma
    • Transformed follicular lymphoma with ≥ 50% diffuse large cell component
  2. Male or female patients 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Measurable disease

Exclusion criteria include the following:

  1. Pregnant or lactating females
  2. Known human immunodeficiency virus (HIV) positive or AIDS-related illness
  3. Any serious medical or psychiatric illness that could interfere with the completion of treatment
  4. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN)
  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder.
  6. Absolute neutrophil count (ANC) < 1,250/mm3
  7. Platelet count < 75,000/mm3
  8. Calculated creatinine clearance < 30 mL/minute
  9. Autologous stem cell transplant less than 6 months prior to enrollment
  10. Patients who have undergone allogeneic stem cell or organ transplantation
  11. Systemic antineoplastic therapy within 14 days preceding the first dose of study drug treatment
  12. Patients who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 42 days
  13. Patients who have received treatment with radioimmunoconjugates or within 12 weeks
  14. Patients who have received radiotherapy within 21 days prior to first dose
  15. Myocardial infarction within 6 months of enrollment or current history of New York Heart Association(NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  16. Major surgery within 14 days prior to the first dose
  17. Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection
  18. Clinically uncontrolled central nervous system (CNS) involvement.
  19. Inability to swallow capsules
  20. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807495

United States, New Jersey
Hematology Oncology Associates, Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00807495     History of Changes
Other Study ID Numbers: C14004
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: November 2013

Keywords provided by Millennium Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Burkitt Lymphoma
Lymphoma, T-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections