Observational Study for Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) Not Eligible for High-dose Therapy According to the Protocol Alternating R-CHOP and R-cytarabine Chemotherapy Regimen (3+3 Cycles)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 主要终点
- Overall response
研究概览
简要总结
This is an observational study aimed to analyze the effectiveness of treatment of patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin): R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.
详细描述
This is an observational study considered for patients with mantle cell lymphoma meeting the basic inclusion criteria. The study will enrol patients who will be treated according to standard protocol used in the hematologic department. Scheme of treatment: alternating cycles of R-CHOP and R-AraC: R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC.
Baseline procedures:
- CT or PET-CT (positron emission tomography with computed tomography)before starting treatment, after 3 cycles and at the end of treatment (after 6 cycles)
- bone marrow examination before therapy, after 3 cycles and after completion of induction
- maintenance rituximab based of standards of each centre
The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.
Primary objectives include response after induction by PET-CT and PFS (progression-free survival).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •confirmed diagnosis of MCL (hematopathologic examination in the reference centre, with evidence of cyclin D1 or translocation t(11;14) )
- •not eligible for high-dose therapy with autologous stem cell transplantation
- •eligible for R-CHOP or R-COEP-based therapy
- •signed informed consent form with the study and data processing
排除标准
- •non compliance of a patient
- •CNS (central nervous system) involvement with lymphoma
- •ECOG (Eastern Cooperative Oncology Group) >3 or active uncontrolled comorbidities
结局指标
主要结局
Overall response
时间窗: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
PET-CT after induction, and bone marrow examination after induction
次要结局
- Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction(After induction for all patients, who can be evaluated; through study completion, an average of 1 year.)
- Progression-free survival and overall survival(max. 4 years)