EUCTR2016-001499-31-FR进行中（未招募）1 期
A Phase Ib-II Study of tazemetostat (EPZ-6438) in newly diagnosed Diffuse Large B Cell Lymphoma (DLBCL) patients with poor prognosis treated by R-CHOP
YSARC0 个研究点目标入组 133 人开始时间: 2016年10月19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
- 133
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. Patients with an untreated DLBCL de novo or transformed from indolent lymphoma (CD 20 positive) with aaIPI = 2
- •2. Age between 60 and 80 years included
- •3. ECOG performance status of 0, 1 or 2 (0 or 1 only for phase Ib)
- •4. Signed informed consent
- •5. Life expectancy of = 90 days (3 months) before starting tazemetostat
- •6. Adequate renal function as calculated by a creatinine clearance > 40 mL/min by local institutional formula
- •7. Adequate bone marrow function as defined as:
- •- ANC = 1500/mm3 (= 1.5 X 109/L)
- •- Platelets = 75,000/mm3 (= 75 X 109/L) without platelet transfusion dependency during the last 7 days
- •- Hemoglobin = 9 g/dL (may receive transfusion)
- •8. Adequate liver function as defined as:
- •- Total bilirubin = 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
- •- Alkaline phosphatase (in absence of bone disease), alanine aminotransferase (ALT) and asparatate aminotransferase (AST) = 3 X ULN (or = 5 X ULN if there is lymphoma involvement of the liver)
- •- Patients with prior Hepatitis B and C are eligible if for Hepatitis B detection, surface antigen is negative and/or HBV DNA is undetectable, and for Hepatitis C detection, HCV RNA is undetectable.
- •9. Left ventricular ejection fraction (LVEF) > 50% of echocardiography or multiple gated acquisition (MUGA) scan
- •10. Adequate tissue for central retrospective testing of EZH2 mutation status and cell of origin (15 slides of tumor biopsy must be available at screening)
- •11. Males with partners of childbearing potential must agree to use reliable forms of contraception
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Symptomatic central nervous system or meningeal involvement
- •2. Contraindication to any drug contained in the chemotherapy regimen
- •3. Prior treatment with tazemetostat or other inhibitor of EZH2
- •4. Patients who are undergoing active treatment for another malignancy, exceptions include: A patient who has been disease free for 2 years, or a patient with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible
- •5. Patients taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John’s wort) or known substrates of CYP2C8.
- •6. Patients unwilling to exclude Seville oranges, grapefruit juice and/or grapefruit from diet
- •7. Major surgery within 4 weeks before first dose of study drug (minor procedures including transcutaneous biopsy, central line placement are permitted within 2 weeks of enrollment)
- •8. Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition that would impare ability to take tazemetostat
- •9. 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 tazemetostat or ventricular arrhythmia
- •10. Prolonged QTcF >480 msec
- •11. Active uncontrolled infection requiring systemic therapy
- •12. Congenital immunodeficiency or known HIV (human immunodeficiency virus infection)
- •13. Any other major illness that in the investigator’s judgement, will substantially increase the risk associated with the patient’s participation in the study
- •14. Patients who have undergone a solid organ transplant
- •15. Previous treatment for B cell lymphoma, except low dose radiotherapy for follicular lymphoma and glucocorticoids (no more than 14 days before inclusion, 1 mg/kg/day max)
研究者
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