EUCTR2009-009256-20-PL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11月20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
- •1. CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original
- •diagnosis. If an evaluable biopsy or fine needle aspiration (FNA) is
- •performed prior to enrolment to the study it must confirm CD20 positive
- •DLBCL or grade 3b FL. Note: If evidence
- •emerges that the binding of the immunohistochemical antibody to CD20
- •can be blocked by rituximab, demonstration of CD20 positivity in the
- •repeat biopsy/FNA will not be required.
- •2. Refractory to, or relapsed following, first-line treatment with
- •rituximab concurrently with anthracycline- or anthracenedione-based
- •chemotherapy.
- •Relapse is defined as:
- •Biopsy (preferred) or FNA confirmed DLBCL or grade 3b FL after a
- •complete response (CR) or unconfirmed complete response (CRu).
- •However, for subjects relapsing during first-line treatment, biopsy/FNA
- •reconfirmation of the lymphoma is recommended but not mandatory.
- •Subjects must have received rituximab concurrently with at least 6
- •cycles of chemotherapy. However, subjects with stage I/II disease will
- •be eligible if
- •they have received rituximab concurrently with at least 3 cycles of
- •chemotherapy and definitive involved-field radiation therapy.
- •Refractory disease must fulfill one of the following:
- •continuing partial response (PR) from termination of first-line
- •treatment. It is strongly recommended the lymphoma be reconfirmed by
- •biopsy (preferred) or FNA, however, if these procedures are deemed to
- •be inappropriate, then HOVON may determine eligibility following review
- •of the imaging results and disease history.
- •Subjects must have received rituximab concurrently with at least 6
- •cycles of chemotherapy. However, subjects with stage I/II disease will
- •be eligible if they have received rituximab concurrently with at least 3
- •cycles of chemotherapy and definitive involved-field radiation therapy.
- •continuing stable disease (SD) from termination of first-line treatment.
- •Reconfirmation of the lymphoma by biopsy (preferred) or FNA is
- •recommended but not mandatory.
- •Subjects must have received rituximab concurrently with at least 3
- •cycles of chemotherapy.
- •progressive disease (PD). Biopsy or FNA reconfirmation of the
- •lymphoma is recommended but not mandatory.
- •3. Baseline FDG-PET scans must demonstrate positive lesions compatible
- •with CT defined anatomical tumor sites.
- •4. CT scan showing at least:
- •2 or more clearly demarcated lesions/nodes with a long axis >1.5cm
- •and short axis =1.0cm
- •1 clearly demarcated lesion/node with a long axis >2.0cm and short
- •axis =1.0cm.
- •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 does not contraindicate study participation.*
- 另有 7 项未显示
排除标准
- •1. Any previous cancer therapy for the lymphoma, with the exception of:
- •First-line treatment with rituximab and an anthracycline- or
- •anthracenedionebased chemotherapy.
- •Monotherapy rituximab, dosed prior to first-line rituximab combined with chemotherapy, 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 lifethreatening symptoms.
- •Prophylactic testicular radiotherapy for testicular lymphoma.
- •Intrathecal chemotherapy for the prophylaxis of CNS disease.
- •2. Received any of the following treatments within two weeks prior to start of study therapy (unless otherwise stated):
- •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 it does not contraindicate participation in this study.
- •4. Planned post-randomisation glucocorticoid therapy, unless
- •specified by the protocol
- •administered in doses =1mg/kg/day prednisolone (or equivalent dose of other glucocorticoid-refer to the SPM for glucocorticoid equivalent doses)
- •administered 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 it does not contraindicate participation in the study.
- •6. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure (NYHA III-IV), a current LVEF of <40%, and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, unless in the opinion of the investigator it does not contraindicate participation in the study.*
- •7. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation in this study.
- •8. Known lymphoma involvement of the CNS.
- •9. Known or suspected hypersensitivity to study treatments that in the opinion of the investigator 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 HBsAb 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 within 2 years prior to
- •randomization unless in the opinion of the investigator it does not contraindicate participation in the study.
- •Subjects who have been free of malignancy for at least 2 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:
研究者
相似试验
进行中（未招募）
不适用
Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBCEUCTR2009-009256-20-ESGlaxoSmithKline S.A.380
进行中（未招募）
不适用
Ofatumumab for the treatment of lymphomaDiffuse Large B-Cell Lymphoma (DLBCL)MedDRA version: 14.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2009-009256-20-GRGlaxoSmithKline Research and Development Limited380
进行中（未招募）
不适用
Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBCDiffuse Large B-Cell Lymphoma (DLBCL)EUCTR2009-009256-20-IEGlaxoSmithKline Research and Development Limited380
进行中（未招募）
1 期
Ofatumumab for the treatment of lymphomaleaseEUCTR2009-009256-20-GBGlaxoSmithKline Research and Development Limited447
进行中（未招募）
不适用
Ofatumumab for the treatment of lymphomaDiffuse Large B-Cell Lymphoma (DLBCL) and grade 3b follicular lymphomaMedDRA version: 14.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2009-009256-20-DEGlaxoSmithKline Research and Development Limited410