EUCTR2006-001985-17-FR进行中（未招募）1 期
An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine, and Oxaliplatin plus Oral Enzastaurin as Treatment for Patients with Relapsed Diffuse Large B-Cell Lymphoma - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
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 may be included in the study only if they meet all of the following criteria:
- •[1] Histology diagnosis of DLBCL or transformed (CD20+) indolent lymphoma by the World Health Organization classification (Harris et al. 1999) at the time of relapse. In the case that histology diagnosis is not available, cytology diagnosis is accepted.
- •[2] Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Protocol Attachment S013.6; Oken et al. 1982).
- •[3] Have relapsed/progressed after CR, CRu or PR obtained in 1st or 2nd line treatment, or patients that have not progressed after SD obtained in 1st or 2nd line.
- •[4] Prior treatment with at least one anthracycline-containing regimen.
- •[5] Patients must have finished an interval of no less than 4 weeks from the completion of prior chemotherapy before receiving study treatment.
- •[6] Measurable disease according to Cheson criteria (lymph node greater than 1.5 cm in its longest transverse diameter by CT scan) (see Protocol Attachment S013.5).
- •[7] Estimated life expectancy of at least 12 weeks.
- •[8] Patient compliance and geographic proximity that allow adequate follow-up.
- •[9] Adequate organ function including the following:
- •Hepatic: total bilirubin < or = 1.5 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) < or = 2.5 times ULN;
- •Renal: serum creatinine <1.5 times ULN;
- •Adequate bone marrow reserve: platelets =75 x 109/L, absolute neutrophil count (ANC) =1.5 x 109/L.
- •[10] 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 12 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 3 days prior to study enrollment.
- •[11] Have given informed consent.
- •[12] =60 years or <60 (but =18 years) who are not eligible to HDC and ASCT.
- •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 that has not received regulatory approval for any indication at the time of study entry.
- •[14] Allogeneic transplantation. Prior autologous transplantation is allowed.
- •[15] More than 2 prior anti-cancer treatment regimens.
- •[16] Are pregnant or breastfeeding.
- •[17] Central nervous system (CNS) metastases (unless the patient has completed successful local treatment for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study treatment). In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required.
- •[18] Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
- •[19] Human immunodeficiency virus (HIV) associated lymphomas.
- •[20] Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been disease-free for more than 5 years, are eligible.
- •[21] 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 (see Protocol Attachment S013.4).
- •[22] Inability to swallow tablets.
- •[23] Previous exposure to gemcitabine or oxaliplatin.
- •[24] Are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
研究者
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