Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Establishment of maximum tolerable dose of valproate.
研究概览
简要总结
Patients with previously untreated diffuse large B-cell lymphoma will receive standard treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD 20-expression.
Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Histologically confirmed (according to the WHO classification) diffuse large B-cell lymphoma stage II-IV
- •No previous treatment for lymphoma. Corticosteroids for alleviation of lymphoma associated symptoms are allowed
- •WHO performance status 0-2
- •HIV negativity
- •Seronegativity for HCV, HBsAg, anti-HBc, or other active infection uncontrolled by treatment
- •Absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study
- •Absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study
- •Absence of hearing impairment > grade 2
- •Absence of porphyria
- •In females: absence of pregnancy and lactation
- •All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
- •All subjects must agree not to share study medication with another person, and to return all unused study drug to investigators
- •Written informed concent according to ICH/GCP and Swedish regulations
排除标准
- 未提供
研究组 & 干预措施
Single, open labeld.
干预措施: Prednisone (Drug)
Single, open labeld.
干预措施: Valproate (Drug)
Single, open labeld.
干预措施: Rituximab (Drug)
Single, open labeld.
干预措施: Cyclophosphamide (Drug)
Single, open labeld.
干预措施: Doxorubicin (Drug)
Single, open labeld.
干预措施: Vincristine (Drug)
结局指标
主要结局
Establishment of maximum tolerable dose of valproate.
时间窗: Participating patients will be followed during study treatment (6 cycles of chemotherapy); 12 weeks or 18 weeks depending on cycle length (14 or 21 days).
次要结局
未报告次要终点