CHOEP-14 + Rituximab With CNS Prophylaxis in Patients Less Than 65 Years With Diffuse Large B-Cell Lymphoma/Follicular Lymphoma Grade III, Stage II-IV With Risk Factors (Age Adjusted IPI) ≥ 2. A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Time to treatment failure
研究概览
简要总结
The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could improve time to treatment failure and reduce the risk of CNS relapses. Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be compared to a historical Nordic study.
详细描述
Pathology:
Patients may be included on the bases of the histological diagnosis of the local pathologist. The specimen will be reviewed by a central pathologist in each country
Treatment:
All patients receive CHOEP-14 with rituximab x 6 with the support of G-CSF followed by high dose cytarabine i.v. and high dose methotrexate i.v.Intrathecal (i.t.) CNS prophylaxis in combination with chemotherapy is not to be given, but i.t. methotrexate may be given once after initial liquid sampling. Radiotherapy will be given at the discretion of the individual centres.
Investigations before, during and after treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 - < 65 years.
- •Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry:
- •Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and cases with leptomeningeal lymphoma involvement. Morphologically discordant lymphomas (most often follicular lymphoma and diffuse large cell B-cell lymphoma in different biopsy specimens, e.g. lymphatic gland and bone marrow) and transformed lymphomas are not to be included.
- •Follicular lymphomas grade III The diagnosis made by the local pathologist of the participating centre will be accepted for registration
- •Patients in at least stage II with age adjusted IPI score of 2 or 3:
- •Stage III /IV and elevated LDH and/or WHO performance status 2 - 3 Stage II and elevated LDH and WHO performance status 2 -
- •Previously untreated.
- •Performance status < 4 (Appendix 2).
- •Written informed consent
排除标准
- •Severe cardiac disease: cardiac function grade 3-4 (Appendix 2) or Left Ventricular Ejection Fraction (LVEF) < 45% (based on MUGA scintigraphy or echo Doppler cardiography).
- •Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- •Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- •Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons.
- •Known HIV positivity.
- •Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ.
- •Uncontrolled infectious disease.
- •Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol.
研究组 & 干预措施
Chemoimmunotherapy
干预措施: R-CHOEP14x6+HD-AraC+HD-Mtx (Drug)
结局指标
主要结局
Time to treatment failure
时间窗: 5 years
Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day.
次要结局
- Number of participants with adverse events(Treatment period (5 years))
- Clinical response rate(Treatment period (5 years))
- Time to progression(5 years)
- Overall survival(5 years)
- Incidence of CNS relapse(Treatment period (5 years))
- Molecular factors important for clinical outcome(Treatment period (5 years))