EUCTR2006-002584-70-GB进行中（未招募）1 期
A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •- Male or female subjects aged 18 years or older.
- •- Histologically confirmed primary Diffuse Large B-Cell Lymphoma (DLBCL) of any stage.
- •- Refractory to the last treatment regimen, defined as one of the following:
- •o The subject failed to obtain at least a Partial Response (PR) at anytime while receiving the last treatment regimen.
- •o The subject obtained at least a PR during the last treatment regimen, but later progressed while still on the treatment regimen.
- •o The subject obtained at least a PR to the last treatment regimen, but progressed within 6 months following completion of the last treatment regimen.
- •- Subjects must have been previously treated with the following treatment regimens:
- •o Anthracycline-based combination chemotherapy with rituximab
- •o Second-line combination chemotherapy
- •o Autologous bone marrow transplant (BMT) or autologous peripheral blood stem cell transplant (PBSCT) if eligible and did not refuse. Subjects that were not eligible for an autologous BMT or PBSCT or subjects that were eligible and refused the procedure are candidates for this trial.
- •- At least one measurable lesion defined as > or equal to 1.5 cm in the longest transverse diameter by CT scan
- •- No known central nervous system (CNS) involvement
- •- Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 2
- •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
- •- Transformed, discordant or composite lymphoma.
- •- Any therapy for lymphoma within 21 days prior to the first YM155 dose.
- •- Within 4 weeks of the baseline FDG-PET scan, subjects cannot have had the following:
- •o Radiation therapy.
- •o Surgical procedures (except biopsies and central catheter / port placement).
- •o Active infection (bloodstream or deep tissue).
- •- Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
- •o Serum creatinine superior or equal to 1.5 x Upper Limit of Normal (ULN) or calculated serum creatinine clearance < 60 mL/min.
- •o Absolute Neutrophil Count (ANC) inferior or equal to 750/mm3.
- •o Platelet inferior or equal to 50,000/mm3.
- •o Alanine Transaminase (ALT) and Aspartate Transaminase (AST) superior or equal to 2.5 x ULN; superior or equal to 5 x ULN if secondary to liver metastases.
- •- Subjects received > 3 prior treatment regimens for their lymphoma. The following should be considered when determining the number of prior treatment regimens:
- •o Any planned maintenance therapy should be considered as part of the previous treatment regimen
- •o Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or autologous PBSCT as one treatment regimen.
- •- Allogeneic BMT or allogeneic PBSCT.
- •- History of other malignancy requiring treatment within 2 years prior to the first dose of YM155, except for treated basal or squamous cell carcinoma of the skin or in situ cervical cancer
研究者
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