Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles
研究概览
简要总结
This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.
详细描述
1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.
The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).
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Consolidation 1A (in case of PET 2- PET 4 -):
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High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days.
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Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days
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Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days.
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Consolidation 2 A (in case of PET 2+ PET4 -):
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2 cycles high-dose Methotrexate with folinic acid rescue
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High dose with Z- BEAM conditioning regimen followed by autologous transplant.
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Salvage(in case of PET 4 +):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- •Age from18 to 59 years, eligible for transplant.
- •Patient not previously treated.
- •Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
- •Index prognostic factors (IPI) 2 or
- •With a minimum life expectancy of 3 months.
- •Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).
- •Having previously signed a written informed consent.
排除标准
- •Any other histological type of lymphoma.
- •Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- •Central nervous system or meningeal involvement by lymphoma.
- •Contra-indication to any drug contained in the chemotherapy regimens.
- •Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- •Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
- •Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.
- •Any serious active disease (according to the investigator's decision).
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
- •Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- •Adult patient under tutelage.
- •Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning
研究组 & 干预措施
R-CHOP-14
R-CHOP14 induction regimen
干预措施: R-CHOP14 induction regimen (Drug)
R-ACVBP14
R-ACVBP14 induction regimen
干预措施: R-ACVBP14 induction regimen (Drug)
结局指标
主要结局
Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles
时间窗: 4 inductive cycles with R-ACVBP14 or R-CHOP14
次要结局
- Response according to PET after 2 cycles, 4 cycles Induction toxicities Response duration Disease-, progression-, event-free and overall survival after autologous transplant Biological factors for prognosis Pharmacokinetic of rituximab(2 cycles and 4 cycles Induction)