EUCTR2009-009256-20-CZ进行中（未招募）不适用
Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBC
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 380 人开始时间: 2009年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. CD20 positive DLBCL. Biopsies performed after termination of first-line treatment must confirm CD20 positive DLBCL.
- •2. Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline-based chemotherapy. Relapse is defined as biopsy confirmed CD20 positive DLBCL after a complete response.
- •Refractory disease must fulfill one of the following:
- •partial response (PR) after termination of first-line treatment. Subjects must have received at least 6 cycles of rituximab combined with anthracycline-based chemotherapy. Subjects with stage I/II disease will also be eligible if treated with at least 3 cycles of rituximab combined with anthracycline-based chemotherapy and definitive involved-field radiation therapy. Biopsy confirmation of CD20 positive DLBCL is required.
- •stable disease (SD) after termination of first-line treatment. Subjects must have received at least 3 cycles of rituximab combined with anthracycline-based chemotherapy. Biopsy confirmation of CD20 positive DLBCL is preferred but not required.
- •progressive disease (PD). Biopsy confirmation of CD20 positive DLBCL is preferred but not required.
- •Disease response to first-line treatment should be determined according to Revised Response Criteria for Malignant Lymphoma [Cheson, 2007], or if PET scanning was not used, International Workshop Response criteria for NHL [Cheson, 1999].
- •3. Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumor
- •4. CT scan showing at least:
- •2 or more clearly demarcated lesions/nodes with a long axis =1.5 cm and short axis =1.0 cm not previously irradiated
- •1 clearly demarcated lesion/node with a long axis =2.0 cm and short axis =1.0 and not previously irradiated.
- •5. Age =18
- •6. ECOG performance status 0, 1, or 2.
- •7. Eligible for high dose chemotherapy and ASCT.
- •8. Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator or GSK Medical Monitor does not contraindicate study participation.
- •9. Written informed consent.
- •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
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Any previous cancer therapy for DLBCL, with the exception of:
- •First-line treatment with rituximab in combination with an anthracycline-based chemotherapy
- •Monoterapy Rituximab, dosed prior to first line rituximab combied with chemoterapy, or as maintenance therapy
- •Radiotherapy as part of the first-line treatment plan
- •Radiotherapy to a limited field at a maximum dose of =10Gy to control
- •life-threatening symptoms.
- •2. Received any of the following treatments within 4 weeks prior to start of study therapy (unless otherwise
- •Anti-cancer cytotoxics (e.g. alkylating agents, anti-metabolites, purine analogues)
- •Radiotherapy unless it is to a limited field at a maximum dose of =10Gy to control life-threatening symptoms.
- •3. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study unless in the opinion of the investigator and Medical Monitor it does not contraindicate participation in this study
- •4. Glucocorticoid use, unless
- •- adiminstrated in doses =100mg/day hydrocortisone (or equivalent dose of other glucocorticoid-refer to the SPM for glucocorticoid equivalent doses) for <7 days
- •-admistrated as inhalation therapy for mild COPD or asthma
- •5. History of significant cerebrovascular disease or event with significant symptoms or sequelae. unless in the opinion of the investigator and Medical Monitor it does not contraindicate participation in this study
- •6. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities unless in the opinion of the investigator and Medical Monitor it does not contraindicate participation in this study
- •7. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator and Medical Monitor contraindicates participation in this study
- •8. Known DLBCL involvement of the CNS.
- •9. Known or suspected hypersensitivity to study treatments that, in the opinion of the investigator or GSKmedical Monitor, contraindicates their participation
- •10. Known HIV positivity.
- •11. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive regardless of HBs Ab status), a HB DNA test will be performed and if positive the subject will be excluded.
- •12. Active hepatitis C infection.
- •13. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis.
- •14. Other past or current malignancy unless in the opinion of the investigator and Medical Monitor it does not contraindicate participation in this study. For example subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •15. Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab .
- •16. Screening laboratory values:
- •platelets <100 x 10^9/L (unless due to DLBCL involvement of the
研究者
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