EUCTR2016-003703-62-IT进行中（未招募）1 期
A phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years) with aggressive B-Cell lymphomas. - FIL_DEVEC
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 60 人开始时间: 2021年10月1日最近更新:
适应症
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
- 60
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
- •Histologically confirmed diagnosis of aggressive Non-Hodgkin lymphomas (NHLs)* including:
- •- Diffuse large B-Cell lymphoma (DLBCL);
- •- Large B Cell Lymphomas;
- •- Grade IIIb follicular lymphoma;
- •- Burkitt lymphoma (Swerdlow SH et al, 2008);
- •- High grade B-cell lymphomas (Swerdlow SH, et al. 2016);
- •- B-Cell unclassifiable lymphomas with features intermediate between DLBCL and BL (Campo E et al, 2011) or between DLBCL and Hodgkin’s lymphoma (HL).
- •* only for patients at disease onset or R/R with initial diagnosis of T-NHL.
- •Age >65 years.
- •Unfit or frail patients (the latest defined, for the purpose of this study, as those who have a maximum of 1 frail factor) according to the multidimensional geriatric evaluation model of the elderly platform of the FIL, who relapsed/progressed after one or maximum two previous lines of treatment or
- •Super-frail” elderly patients at disease onset: eligible super-frail patients are defined, for the purpose of this study, as those who have a maximum of 2 frail factors, according to the CGA adopted in the elderly platform of the FIL, among those below listed:
- •- ADL = 4;
- •- IADL = 5;
- •- Age = 80 years;
- •- 1 CIRS grade 3 or >8 CIRS grade 2.
- •Ann Arbor stage I bulky to IV
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •Life expectancy >1-2 months.
- •Adequate renal function (creatinine = 2 mg/dl, unless secondary to lymphoma).
- •Adequate liver function (bilirubin = 2 mg/dl, unless secondary to lymphoma).
- •Absolute neutrophil count (ANC) =1,500 cells/mmc, platelets = 50,000 cells/mmc, and hemoglobin = 9.5 gr/dL (unless cytopenia is related to marrow involvement by lymphoma).
- •Availability of adequate care by family members or other caregivers.
- •Written informed consent signature.
- •Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following the end or the discontinuation from the study treatment even if he has undergone a successful vasectomy.
- •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 60
排除标准
- •Patients who received more than two previous chemotherapy lines.
- •Stage I, who may be treated with a short course of chemotherapy and radiotherapy.
- •Patients with CNS involvement
- •Relapsed/refractory patients with fit profile.
- •Fit, unfit, and frail patients at disease onset.
- •Patients with a high fragility functional status, defined, for the purpose of this study, as with > 1 CIRS grade 3 or 1 CIRS grade 3 and >8 CIRS grade 2.
- •Super-Frail patients with more than 2 frail factors.
- •Patient with Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Malabsorption syndrome or other diseases that affect the ability to swallow oral therapy.
- •Concomitant malignancy requiring treatment (except non-melanoma skin cancers and in situ carcinoma of the uterine cervix).
- •Presence of opportunistic infections in place.
- •Seropositive for or active viral infection with hepatitis B virus (HBV):
- •a. HBsAg positive;
- •b. HBsAg negative, HBcAb positive with detectable viral DNA;
- •Subjects who are HBsAg negative, HBcAb positive, but viral DNA negative are eligible.
- •Seropositive and active infection for hepatitis C virus (HCV); subjects who are HCV-RNA negative are eligible.
- •Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
- •Impossibility to give written informed consent.
研究者
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