Prospective One-center Open Label Observational Efficacy & Safety Study of Chlorambucil & Obinutuzumab in Treatment of Unfit Patients With Untreated Chronic Lympho Leukemia With Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- MRD status of CLL patients with comorbidities
研究概览
简要总结
The study evaluate safety and effectiveness of chlorambucil and obinutuzumab in routine clinical practice in patients with chronic lymphatic leukemia and with certain comorbidities (any cardiac pathology, diabetes mellitus (DM), kidney pathology or cytopenia), whom obinutuzumab & chlorambucil have been applied according to indications before enrollment in the study.
详细描述
MRD (Minimal residual disease) evaluation was chosen as a primary measure outcome as it is considered as prognostic marker for long-term progression freee survival (PFS) and as a potential therapeutic goal in chronic lymphocytic leukemia/ CLL .
Minimal residual disease (MRD-negative) is assessed in the clinic by 8-color flow cytometry giving the sensitivity level of MRD detection 10-5; MRD is measured in real clinical practice at this clinical center according to National recommendations in diagnostics and treatment of lymphoproliferative disorders.
To achieve study objectives medical patients' charts will be analyzed retrospectively. In the frame of this program 104 patients' charts treated in defined clinical site, are planned to be analyzed. This number of patients corresponds to the patient flow with this pathology at a defined clinical site for 1 years.
Data collection is considered to be retrospective as data will be transferred to e-CRF from patient medical charts. During this study no further specific extra procedures for data gathering is expected.
But since patients included in the study will be at the center of ongoing therapy, the study was called a prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20+/ (cluster of differentiation antigen 20 positive) B-CLL pts on the 1st line treatment therapy, whom have been already applied Obinutuzumab and chlorambucil
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group Scale (ECOG) 0-
- •Total Chronic Illness Resources Survey scale (CIRS) score >6 or creatinine clearance <70 ml/min or both for patients ≥ 18 years old or all CLL pts ≥ 75 years old
- •Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l)
- •Life expectancy more than 6 months according to the physician's opinion.
- •Signed informed consent that allow personal data and data that refer to patient confidentiality processing
排除标准
- •The refusal of the patient to participate in the observational study and the withdrawal of informed consent that allow processing of personal data and data that refer to patient confidentiality.
结局指标
主要结局
MRD status of CLL patients with comorbidities
时间窗: 3 months after the last dose of study treatment
Number of patients with positive and negative MRD status
次要结局
- Response Rate (ORR)(3 months after last dose administration)
- Progression free survival (PFS) by the Kaplan-Meier method(3 months after last dose administration)
- Duration of response (DOR) by the Kaplan-Meier method(3 months after last dose administration)