A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma - LUMIERE

Millennium Pharmaceuticals, Inc0 个研究点目标入组 354 人开始时间: 2012年4月11日最近更新: 2018年4月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Millennium Pharmaceuticals, Inc
入组人数: 354

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Male or female patients age 18 or older
•- Patients with PTCL according to World Health Organization (WHO) criteria (nodal and extranodal disease subtypes) 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 128
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 226

排除标准

•- 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 both of the comparator drugs (pralatrexate, 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%
•- Serum potassium < 3.6 mmol/L or serum magnesium < 0.85 mmol/L
•- 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 and/or chronic 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

研究者

发起方

Millennium Pharmaceuticals, Inc

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