A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator&Apos;s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a single-agent comparator in countries that do not permit its use at this time.

Who is eligible to participate?

Inclusion Criteria: - Male or female patients age 18 or older - Patients with PTCL according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease. - Tumor biopsy available for central hematopathologic review - Measurable disease according to the IWG criteria - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Female patients 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 patients 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 Exclusion Criteria - 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 - Patients 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 - Patients 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 patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients'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 patients 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

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