EUCTR2009-010777-20-GB进行中（未招募）1 期
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin’s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant - N/A
Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 43 人开始时间: 2010年6月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
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
入选标准
- •A subject is eligible for the study if all of the following apply:
- •1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved
- •written Informed Consent and privacy language as per national regulations (e.g.,
- •HIPAA Authorization for U.S. sites) must be obtained from the subject prior to
- •any study-related procedures (including withdrawal of prohibited medication, if
- •applicable).
- •2. Male or female subject aged 18 years or older.
- •3. Any stage, histologically confirmed CD20-positive primary or transformed DLBCL or
- •grade 3 FL.
- •4. Ineligible for or have previously received an ASCT.
- •5. Subject must have relapsed or transformed from a low grade NHL to a DLBCL and have documented at least a PR that was maintained for 3 months prior to progression; following receipt of last dose of systemic chemotherapy or ASCT.
- •6. At least one prior chemotherapy regimen.
- •oPrior regimen must have contained anthracycline (unless contraindicated).
- •oAny planned maintenance therapy should be considered as part of the
- •previous treatment regimen.
- •oAny preparative treatment (salvage chemotherapy, high-dose
- •chemotherapy, radiation therapy, etc.) should be included with the ASCT
- •as one treatment regimen.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status = 1 at the
- •Baseline Visit.
- •8. Life expectancy greater than 12 weeks at the Baseline Visit based on Investigator's judgement.
- •9. At least one measurable lesion = 1.5 cm in the longest diameter (LDi) OR > 1.0 - = 1.5 cm in LDi and > 1.0 cm in the shortest diameter (SDi) as assessed via diagnostic computed tomography (CT) or FDG PET scans.
- •10. Subject with a previous history of non-CD20+ B cell NHL malignancy is eligible only if the subject meets the following:
- •o Previous history of a non-invasive carcinoma if in the opinion of the investigator the subject has had potentially curative treatment prior to enrollment.
- •o For all other malignancies, the subject has undergone potentially curative therapy and has been considered disease free for at least 5 years.
- •11.Female subject must be either:
- •Of non-child bearing potential
- •post-menopausal (defined as at least 1 year without any mensus) prior to Screening, or
- •documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening), or
- •If of childbearing potential,
- •must have a negative serum or urine pregnancy test at Screening
- •must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after final study drug administration.
- •12.Male subject and their female spouse/partners of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 28 days after final study drug administration.
排除标准
- •A subject will be excluded from participation if any of the following apply:
- •1. Use of systemic steroids within 5 days of the Baseline Visit.
- •o A subject receiving steroids at the time of the Baseline Visit is eligible as
- •long as the subject is receiving a biologic dose or has been on a stable,
- •non-biologic dose for at least 4 weeks prior to the first dose of YM155 and
- •plans on continuing to receive the stable, non-biologic dose during study
- •participation.
- •o Systemic steroid use within 5 days of the Baseline Visit for the purposes
- •of pre-medication prior to study regimen treatment is allowed.
- •2. Prior allogeneic stem cell transplant (SCT).
- •3. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
- •o Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated serum
- •creatinine clearance < 60 mL/min.
- •o Absolute neutrophil count (ANC) = 1000/mm3.
- •o Platelet = 75,000/mm3.
- •o Alanine transaminase (ALT) and Aspartate transaminase (AST)
- •= 2.5 x ULN or = 5 x ULN if secondary to liver metastases.
- •4. Central nervous system (CNS) or leptomeningeal involvement by lymphoma as
- •determined by the Investigator through physical examination and medical history
- •review at the Baseline Visit.
- •5. The subject has significant and/or uncontrolled cardiac, renal, hepatic, or other
- •systemic disorders or significant psychological conditions at the Baseline Visit that
- •in the Investigator’s judgment would jeopardize subject enrollment or compliance
- •with the study procedures.
- •6. The subject has known human immunodeficiency virus (HIV), hepatitis B surface
- •antigen, or hepatitis C antibody.
- •7. The subject has been previously treated with YM155.
- •8. The subject has received other investigational therapy or procedures within 21
- •days prior to the first study drug administration.
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