EUCTR2014-005697-10-IT进行中（未招募）1 期
GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin’s lymphoma.A phase II study of the Fondazione Italiana Linfomi (FIL). - FIL_GAE
Fondazione Italiana Linfomi ONLUS0 个研究点目标入组 78 人开始时间: 2015年2月24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
- 78
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) Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade IIIB lymphoma, according to WHO classification (local pathologist)
- •2) Age = 65 years
- •3) No previous treatment
- •4) CGA assessment performed before starting treatment
- •5) UNFIT patients defined as follows (see Appendices A-D):
- •Age > 80 years with FIT profile, i.e.
- •ADL =6 residual functions
- •IADL=8 residual functions
- •CIRS: no comorbidity of grade 3-4 and <5 of grade 2
- •or Age < 80 with UNFIT profile, i.e
- •ADL > 5 residual functions
- •IADL > 6 residual functions
- •CIRS: no comorbidity of grade 3-4 and 5-8 co-morbidities of grade 2
- •6) Ann Arbor Stage I with bulky, II-IV (Appendix E)
- •7) At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan
- •8) ECOG performance status of 0, 1, or 2 (Appendix G)
- •9) Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
- •Hemoglobin = 10 g/dL
- •Absolute neutrophil count = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •10) LVEF >50%
- •11) Ability and willingness to comply with the study protocol procedure
- •12) Life expectancy > 6 months
- •13) Accessibility of patient for treatment and follow up
- •14) Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 78
排除标准
- •1) History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •2) Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- •3) History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- •4) Stage I without bulky
- •5) Patients with transformed lymphoma
- •6) Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
- •7) Previous exposure to cytotoxic agents
- •8) Suspect or clinical evidence of CNS involvement by lymphoma
- •9) HBsAg, HCV or HIV positivity; isolated HBcAb positivity is accepted only with concomitant treatment with Lamivudine
- •10) AST /ALT > twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl (unless these abnormalities were related to the lymphoma)
- •11) Evidence of any severe active acute or chronic infection
- •12) Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
研究者
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