Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Completed · Phase 3

Conditions studied: Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma

In brief

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

Key facts

Study ID

NCT01482962

Run by

Millennium Pharmaceuticals, Inc.

People needed

271

Starts

2012-06-11

Expected to finish

2017-12-18

Last updated by the study team

2018-07-31

Who can join

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

You may qualify if…

• Male or female participants age 18 or older
• Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease.
• Tumor biopsy available for central hematopathologic review
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Female participants who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
• Male participants who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
• Suitable venous access
• Voluntary written consent

You may not qualify if…

• Known central nervous system lymphoma
• Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
• Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity)
• History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
• Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
• Concomitant use of other medicines as specified in study protocol
• Participants with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
• Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
• Autologous stem cell transplant less than 3 months prior to enrollment
• Participants who have undergone allogeneic stem cell or organ transplantation any time
• Inadequate blood levels, bone marrow or other organ function as specified in study protocol
• The participant must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to participant's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
• Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
• Female participants who are breastfeeding or pregnant
• Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
• Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol

Where it is running

• Study site — La Jolla, California, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Jefferson City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Charleston, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Seattle, Washington, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Adelaide, Australia
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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