EUCTR2008-005496-10-IE进行中（未招募）不适用
An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin versus R-CHOP in the First-Line Treatment of Patients with Intermediate and High-Risk Diffuse Large B-Cell Lymphoma - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Patients are eligible to be included in the study only if they meet all of the following
- •[1] Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be
- •eligible for enrollment.
- •[2] Have received no prior chemotherapy.
- •[3] Have an IPI score =2 at time of original diagnosis (Protocol Attachment S028.5).
- •[4] Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale (Protocol Attachment S028.4; Oken et al. 1982).
- •[5] Have adequate organ function as follows:
- •Hepatic: total bilirubin =1.5 times the upper limit of normal (× ULN); alanine transaminase (ALT) and aspartate transaminase (AST) =1.5 × ULN, (=5 × ULN, if liver involvement).
- •Renal: serum creatinine =1.5 × ULN
- •Adequate bone marrow reserve: platelets =75 × 109/L, absolute neutrophil count (ANC) =1.0 × 109/L, unless there is bone marrow involvement.
- •[6] Have a normal left ventricular ejection fraction of =50% by echocardiography or nuclear medicine multi-gated (MUGA) scan.
- •[7] Are at least 18 years of age.
- •[8] Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test =3 days prior to study enrollment.
- •[9] Must agree to participate in PGx sampling and analysis.
- •[10] Have an estimated life expectancy of at least 12 weeks.
- •[11] Must sign an informed consent document (or legal representative has given informed consent).
- •[12] Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[13] Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
- •[14] Are receiving concurrent administration of any other systemic anticancer therapy.
- •[15] Are pregnant or breastfeeding.
- •[16] Are unable to swallow tablets.
- •[17] Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment (Protocol Attachment S028.3).
- •[18] Have a serious concomitant systemic disorder, including active bacterial or fungal infection, incompatible with the study (at the discretion of the investigator).
- •[19] Have human immunodeficiency virus (HIV) associated lymphomas.
- •[20] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (Protocol Attachment S028.6).
- •[21] Have a prior malignancy (other than DLBCL, or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- •[22] Have central nervous system (CNS) metastases. A screening CT or MRI before enrollment in the absence of a clinical suspicion of brain metastases is not required.
- •[23] Have previously received enzastaurin therapy in any other clinical trial
研究者
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