EUCTR2015-003371-29-IT进行中（未招募）1 期
A combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.A phase II study of the Fondazione Italiana Linfomi (FIL). - Not available
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 68 人开始时间: 2020年11月4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
- 68
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, according to WHO classification (local pathologist)
- •2. Age = 70 years
- •3. Previously untreated
- •4. CGA assessment performed before starting treatment
- •5. FRAIL patients defined as follows:
- •Age >= 80 years (with UNFIT profile):
- •ADL >= 5 residual functions and/or
- •IADL >= 6 residual functions and/or
- •CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2
- •Age < 80 (ONLY one of the following criteria):
- •ADL <= 4 residual functions
- •IADL <= 5 residual functions
- •CIRS: 1 comorbidity of grade 3-4 or > 8 comorbidities of grade 2
- •6. Ann Arbor Stage I - IV
- •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- 3
- •9. No active hepatitis C virus (HCV) infection. In case of HCV positivity HCV-RNA is required. Only patients with HCV-RNA negative are accepted.
- •10. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
- •- Hemoglobin > 10 g/dL
- •- WBC > 2500/mmc with PMN > 1000/ mmc
- •- Platelets count = 75000/mmc
- •- Creatinine clearance = 10 mL/min
- •11. Ability and willingness to comply with the study protocol procedure
- •12. Life expectancy > 6 months
- •13. Patients must give written informed consent.
- •14. Male subjects must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, 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 68
排除标准
- •1. Histological diagnosis different from CD20 positive Diffuse Large B-cell Lymphoma are excluded.
- •2. Previous exposure to cytotoxic agents
- •3. Suspect or clinical evidence of CNS involvement by lymphoma
- •4. Contraindication to the use of Rituximab or of Lenalidomide
- •5. HBsAg positivity; HBsAg-negative patients with anti-HBc antibody can be enrolled if Hepatitis B Virus (HBV)-DNA are negative and antiviral treatment with Lamivudine or Tenofir is provided.
- •6. HIV positivity
- •7. Active herpes zoster infection; previously infected patients is accepted only with concomitant treatment with Valacyclovir
- •8. Any 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
- •9. AST /ALT > 2 x UNL; bilirubin > 2 x UNL; serum creatinine > 2.5 mg /dL
- •10. Creatinine clearance < 10 mL/min
- •11. Evidence of any severe active acute or chronic infection
- •12. Severe cardiac dysfunction (NYHA grade III-IV)
- •13. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- •14. Absence of caregivers in non-autonomous patients
研究者
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