EUCTR2011-003545-18-DE进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 354
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
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