EUCTR2016-003716-12-DE进行中（未招募）1 期
Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited0 个研究点目标入组 122 人开始时间: 2018年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
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
- •1. Male or female patients aged 18 years or older.
- •2. Patients must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations (double-hit
- •DLBCL under DLBCL, NOS, based on the 2008 WHO classification criteria) is not eligible for this study.
- •a. Local pathology review for histological confirmation:
- •- A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
- •3. Relapsed or refractory to =2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
- •4. For patients who have relapsed or progressed after achieving a response, documented, investigator-assessed relapse or progression after the last treatment is required.
- •5. Must have FDG-PET–avid measurable disease that meets the size criteria per IWG as assessed on cross-sectional imaging by CT/MRI.
- •6. ECOG performance status score of 0 or 1.
- •7. Life expectancy of >3 months
- •8. Patients must have adequate organ function, including the following:
- •a. Bone marrow reserve: absolute neutrophil count (ANC) =1000/µL, platelet count =75,000/µL (=50,000/µL for patients with bone marrow involvement), and hemoglobin =8 g/dL (red blood cell [RBC] and
- •platelet transfusion allowed =14 days before assessment).
- •b. Hepatic: total bilirubin =1.5 times the upper limit of the normal range (ULN); ALT and AST =2.5xULN.
- •c. Renal: creatinine clearance =60 mL/min either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
- •Lipase =1.5xULN and amylase =1.5xULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
- •Blood pressure =Grade 1 (hypertensive patients are permitted if their blood pressure is controlled to =Grade 1 by hypertensive medications and glycosylated hemoglobin is =6.5%).
- •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 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 73
排除标准
- •1. CNS lymphoma; active brain or leptomeningeal metastases.
- •2. Known human immunodeficiency virus (HIV)–related malignancy.
- •3.Known hypersensitivity reactions to the active substance or to any of the excipients of the study drug.
- •4. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment.
- •5. Radiotherapy less than 3 weeks before the first dose of study treatment.
- •6. Known HIV positive (testing not required).
- •7. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
- •8. Prior ASCT within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
- •9. Participants with certain cardiovascular conditions are excluded.
- •10. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
- •11. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
- •12. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
- •13. Patients with another malignancy within 2 years of study start. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are
- •considered disease-free at the time of study entry.
- •14. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
- •15. Certain wash-out restrictions before the first dose of study drug on inhibitors of P-gp and/or strong reversible inhibitors of CYP3A, strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or Pgp inducers, grapefruit containing food or beverages.
研究者
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