NCT01719835Unknown2 期
CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- complete response rate (CR/CRu)
研究概览
简要总结
This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.
详细描述
Background:
T-cell lymphoma is an aggressive rare subset of Non-Hodgkin lymphoma (NHL) comprising several different subtypes of disease within this group. No standard first-line treatment exists for T-cell lymphoma as published series are small, with heterogeneous populations and often retrospective.
Protocol Synopsis, Study Period: 5 years
Objectives:
Primary:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, histologically proven T-cell Lymphoma (any of the following):
- •Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS)
- •Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only
- •Angioimmunoblastic T-cell lymphoma
- •Hepatosplenic gamma/ delta T-cell lymphoma
- •Enteropathy-associated T-cell lymphoma (EATL)
- •Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV.
- •Patient is male or female, and ≥18 years of age on the day of signing informed consent.
- •WHO performance status 0, 1 or
- •Cross sectional imaging from a baseline contrast enhanced CT should show at least one measurable disease site that is at least 2 cm in longest diameter and measurable in two perpendicular dimensions with or without corresponding Fluorodeoxyglucose(FDG) avid lesions.
- •Adequate cardiac function; formal assessment of left ventricular ejection fraction is only required if clinically indicated (a baseline echocardiogram should be done for patients with either hypertension, age > 60 years or history of cardiac disease)
- •Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.0x109/l; white blood cell count ≥ 3x109/l; platelets ≥ 100x109/l; haemoglobin (Hb) ≥ 9g/dl (can be post-transfusion), unless deemed disease related
- •Adequate renal function: calculated creatinine clearance ≥50ml/minute.
- •Adequate liver function: serum bilirubin ≤1.5x Upper limit of normal (ULN); Alanine transaminase/Aspartate transaminase (ALT/AST) ≤2.5x ULN; ALP ≤3x ULN (in the absence of liver metastases). If liver metastases are present, ALT, AST or Alkaline phosphatase (ALP) ≤5x ULN are permitted. Isolated hyperbilirubinaemia due to Gilbert's disease is acceptable
- •Female patient of childbearing potential must have a negative serum or urine β-human chorionic gonadotropin(hCG)pregnancy test at baseline.
- •Written informed consent must be obtained prior to start of study treatments. Scans and bone marrow biopsies performed within 4 weeks of commencement of therapy will be acceptable provided they have been performed according to study requirements.
- •Patient agreeable to use contraception for the period of study treatment and up to 12 months after the last dose of study drugs.
排除标准
- •Documented or symptomatic central nervous system involvement or leptomeningeal disease.
- •Patients with no measurable disease on the contrast enhanced CT scan at baseline.
- •Any other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial.
- •Any other malignancies diagnosed or treated within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
- •Treatment with another investigational agent within 30 days of commencing study treatment.
- •Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or active hepatitis B infection.
- •Patient is pregnant or breastfeeding, or expecting to conceive or father children within one year of finishing study treatment.
- •Patients with poorly controlled diabetes mellitus
- •Hypersensitivity or contraindication to any of the study drugs as stated in the Summaries of product characteristics(SmPCs)for each of the study drugs. Patients with previous cardiac infarct but satisfactory cardiac function may be allowed at the discretion of Chief Investigator.
研究组 & 干预措施
Chemotherapy GEM-P
Experimental
Gemcitabine, Methylprednisolone, Cisplatin
干预措施: Gemcitabine (Drug)
Chemotherapy GEM-P
Experimental
Gemcitabine, Methylprednisolone, Cisplatin
干预措施: methylprednisolone (Drug)
Chemotherapy GEM-P
Experimental
Gemcitabine, Methylprednisolone, Cisplatin
干预措施: Cisplatin (Drug)
Chemotherapy CHOP
Active Comparator
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
干预措施: Cyclophosphamide (Drug)
Chemotherapy CHOP
Active Comparator
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
干预措施: Doxorubicin (Drug)
Chemotherapy CHOP
Active Comparator
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
干预措施: Vincristine (Drug)
Chemotherapy CHOP
Active Comparator
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
干预措施: Prednisolone (Drug)
结局指标
主要结局
complete response rate (CR/CRu)
时间窗: approximately 20 weeks after randomisation
次要结局
- Overall Survival(1 and 2 years)
- Progression Free survival(1 and 2 years)
- Toxicity(approximately 20 weeks after randomisation)
- Metabolic Complete Response Rate(approximately 20 weeks after randomisation)
研究者
研究点 (1)
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