NCT00901069已完成1 期
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial
Shams Shakil1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma
研究概览
简要总结
This is a phase I, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.
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
- •Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- •Age ≥ 18 years and without a maximum age.
- •All patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception.
- •Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.
- •Patients must have relapsed lymphoma.
- •ECOG performance status of 2 or better.
排除标准
- •Pregnant or breast-feeding at the time of proposed study entry
- •Clinical AIDS or ARS or known positive HIV serology
- •History of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease
- •Psychiatric or additive disorders that would preclude obtaining informed consent
- •Serum bilirubin > 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these are attributed to active hemolysis
- •Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels > 2 times ULN
- •Serum creatinine levels > 1.5 times ULN
- •Platelets < 75,000/mm3
- •Absolute neutrophil count < 1500/mm3
- •Active infection including viral hepatitis
- •Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab
- •Grade 3 or 4 neuropathy
- •Advanced hepatic tumors
- •Uncompensated heart failure
研究组 & 干预措施
Azacitidine
Other
干预措施: Azacitidine with rituximab, vincristine, and cyclophosphamide (Drug)
结局指标
主要结局
Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma
时间窗: Eight 21 day cycles
次要结局
未报告次要终点
研究者
Shams Shakil
Principal Investigator
University of Kentucky
研究点 (1)
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