Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma

Weill Medical College of Cornell University1 个研究点分布在 1 个国家目标入组 14 人开始时间: 2010年1月最近更新: 2017年4月10日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Weill Medical College of Cornell University
入组人数: 14
试验地点: 1
主要终点: Complete Response

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients must have histologically confirmed DLBCL with characteristic immunophenotypic profiles. Tumor tissue must be confirmed to express the CD20 antigen by flow cytometry or immunohistochemistry.
•Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
•Patient has not had any previous treatment.
•Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III or IV disease
•Able to adhere to the study visit schedule and other protocol requirements.
•Patients must have laboratory test results within these ranges:
•Absolute neutrophil count > = 1500/mm³
•Platelet count > = 75,000/mm³
•Serum creatinine < = 1.5X upper limit of normal (ULN)
•Total bilirubin < = 1.5X ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
•AST (SGOT) and ALT (SGPT) < = 2 x ULN
•Disease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
•Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
•Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine. The effects of azacytidine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
•Age >18 years.
•Ability to understand and the willingness to sign a written informed consent document.
•ECOG performance status of 0-2

排除标准

•Patients must not have any serious medical condition, laboratory abnormality,or psychiatric illness that would prevent the subject from signing the informed consent form.
•Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Concurrent use of other anti-cancer agents or treatments.
•Known positive for HIV or infectious hepatitis B.
•Known central nervous system involvement by lymphoma.
•Known or suspected hypersensitivity to azacitidine or mannitol.
•Patients must not have advanced malignant hepatic tumors.
•Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.