A Prospective , Multicenter, RandomizedPhase III Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
This is a prospective , open, multicenter, randomized phase III study. The investigators planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.
详细描述
This is a prospective , open, multicenter, randomized phase III study. We planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.
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randomization Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study.
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Dosage and administration
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Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles.
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Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.
patients with bulky disease or extranodal lesion wil be received radiotherapy after finishing the chemotherapy.
- Study evaluations
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤70 years old.
- •Histological documented high risk T cell lymphoma:extranodal NK/T-cell lymphoma,hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma,angioimmunoblastic T-cell lymphoma,enteropathy-type T-cell lymphoma, peripheral T-cell lymphoma,unspecified.
- •Measurable disease and evaluable lesion.
- •Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.
- •Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L)
- •ECOG Performance status 0-3,Life expectancy of at least 3 months.
- •Without history of another malignancy
- •Without any conflict serious systemic disease
- •Without any accompany treatment(including steroids drugs)
- •Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening.
排除标准
- •Patients with prior clinical study within 3 months.
- •Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy
- •Transformed lymphoma
- •Mycosis fungicide/Sézary syndrome（MF/SS）
- •History of allergic reaction to any ectogenic proteins
- •Prior treatment for lymphoma .
- •History of another malignancy
- •Neutrophil count < 1.0× 109/L ,hemoglobin < 90g/L,platelets < 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection.
- •Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months
- •Serious infective or organic disease
- •Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal)
- •liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl)
- •clinical syndrome of encephalon functional disorder,serious psychosis
- •female subject who is pregnant or breast-feeding
研究组 & 干预措施
CHOP
CHOP regimen Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles.
干预措施: chemotherapy (CHOP) (Drug)
c-ATT regimen
c-ATT regimen Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.
干预措施: chemotherapy(c-ATT) (Drug)
结局指标
主要结局
5-year overall survival
时间窗: 5-year
次要结局
- SAEs(5year)
- DFS(5-year)
- quality of life(5year)
- RR rate(5year)
- CR rate(5year)
- PR rate(5year)
- progression of disease rate(5year)
研究者
Tongyu Lin
vice chairman of department of medical oncology
Sun Yat-sen University