EUCTR2006-002584-70-FR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
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 Diffuse Large B-Cell Lymphoma (DLBCL) (including transformed 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 Remission (PR) at anytime while receiving the previous treatment regimen.
- •o The subject obtained at least a PR during the previous treatment regimen, but later progressed while still on the treatment regimen.
- •o The subject obtained at least a PR to the previous treatment regimen, but progressed within 6 months following completion of the previous treatment regimen.
- •- Subjects who have not received an autologous Bone Marrow Tansplant (BMT) or autologous Peripheral Blood Stem Cell Transplant (PBSCT) must have refused or been ineligible for that procedure.
- •- At least one measurable lesion defined as superior or equal to 1.5 cm in the longest transverse diameter by CT scan.
- •- No known central nervous system involvement.
- •- Eastern Cooperative Oncology Group (ECOG) performance status inferior 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
- •- 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. Subjects are permitted to have had an autologous BMT or autologous PBSCT as one of the prior treatment regimens. If a subject has had an autologous BMT or autologous PBSCT, it, along with any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) is included as one treatment regimen.
- •- Allogeneic BMT or allogeneic PBSCT.
- •- History of other malignancy requiring treatment within 5 years, except for treated basal or squamous cell carcinoma of the skin or in situ cervical cancer
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