EUCTR2016-003103-56-BE进行中（未招募）1 期
A phase Ib - II study of Entospletinib (ENTO) in newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL) patients with aaIPI =1 treated by R-CHOP
YSARC0 个研究点目标入组 136 人开始时间: 2017年3月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
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
入选标准
- •1. Patients with histologically confirmed de novo DLBCL (CD20 positive)
- •2. Age between 60 and 80 years included, on the day of the informed consent document signature
- •3. Age adjusted International Prognosis Index (aaIPI) score = 1
- •4. No prior treatment for DLBCL. However prephase treatment with 1mg/kg/day prednisone or equivalent, for a maximum of 14 days, is permitted prior to begin the treatment
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (0 or 1 only for phase 1b)
- •6. Life expectancy of = 90 days (3 months) before starting Entospletinib
- •7. Signed informed consent
- •8. At least one bi-dimensionally measurable lesion defined as at least one node or tumor lesion on CT scan = 1.5 cm
- •9. FDG PET/CT performed at baseline with a FDG positive result
- •10. Adequate hematologic functions defined as follows (unless secondary to bone marrow involvement by lymphoma):
- •- Absolute neutrophil count (ANC) > 1.5 X 10^9 G/l and
- •- Platelets count = 75 X 10^9/l without platelet transfusion dependency during the last 7 days and
- •- Haemoglobin level > 9 g/dl (may receive transfusion)
- •11. Adequate liver function defined as follows:
- •- Total bilirubin <1.5 upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome and
- •- Alkaline phosphatase (in absence of bone disease), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 X ULN
- •12. Adequate renal function as calculated by a creatinine clearance > 40 ml/min by local institutional formula
- •13. Patients with prior Hepatitis B must be given antiviral prophylaxis and HBV DNA monitored; Patients with prior Hepatitis C are eligible if, HCV RNA is undetectable.
- •14. Left ventricular ejection fraction (LVEF) = 50% of echocardiography or multiple gated acquisition (MUGA) scan
- •15. Adequate tissue for central retrospective testing for cell of origin (10-15 slides of tumor biopsy must be available at baseline)
- •16. Heterosexually active females of childbearing potential (as defined in the protocol) must:
- •- have a negative serum pregnancy test at baseline and prior to the first study drug administration (C1D-4)
- •- have practiced at least 1 reliable method of contraception for at least 2 months prior to the first study drug administration (C1D-4)
- •- agree to utilize highly effective methods of contraception (as defined in the protocol) from Cycle 1Day -4 until 12 months following the last treatment administration
- •17. Heterosexually active males with partners of childbearing potential must agree to use reliable forms of contraception during treatment and up to 12 months after last treatment administration
- •18. Male subjects must agree to avoid sperm donation from Cycle 1 Day -4 until 12 months following the last treatment administration
- •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 34
- •F.1.3 Elderly (>=65 years) yes
排除标准
- •1. Central nervous system or meningeal involvement with DLBCL
- •2. Contraindication to any drug contained in the chemotherapy regimen
- •3. Prior treatment with Entospletinib or other SYK inhibitor
- •4. Patients with a prior history of other malignancy, exceptions include:
- •- a subject who has been disease-free after curative local treatment (surgical resection) for at least 3 years,
- •- a subject with a history of a completely resected non-melanoma skin cancer or in situ carcinoma with surgical complete excision.
- •5. Patients taking current therapy with proton pump inhibitors and current therapy with medicines that are strong CYP3A or CYP2C9 inducers, or moderate CYP2C9 inducers.
- •6. Ongoing active pneumonitis
- •7. Peripheral sensory or motor neuropathy grade > 1.
- •8. Major surgery within 4 weeks before first dose of study drug (minor procedures including transcutaneous biopsy, central line placement are permitted at any time)
- •9. Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition that would impair ability to take entospletinib
- •10. Significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of first dose of entospletinib or ventricular arrhythmia
- •11. Active infection as judged by the investigator
- •12. Known hypersensitivity to ENTO
- •13. Congenital immunodeficiency or known HIV (human immunodeficiency virus infection) or active viral hepatitis B or C
- •14. Any other major illness that in the investigator’s judgement, will substantially increase the risk associated with the subject’s participation in the study
- •15. Subjects who have undergone a solid organ transplant and stem cell transplant
- •16. Previous treatment for B cell lymphoma or Richter’s transformation
- •17. Primary Mediastinal B Cell Lymphoma
研究者
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