Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
研究概览
简要总结
Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy treatment.
详细描述
Methotrexate and interferon are widely used drugs in treatment in patients with cutaneous T-cell Lymphomas. Efficacy and safety of both drugs have never been compared directly in one study.
Patients will be randomly assigned to receive Methotrexate or Interferon Alfa 2b. Treatment will continue until disease progression or the development of intolerable toxicities. Study is conducted to analyse and compare efficacy, safety and quality of life provided by Methotrexate or Interferon Alfa 2b.
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
- •Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)
- •Age ≥ 18 years
- •Performance status WHO<=2
- •Subject must have adequate bone marrow, renal and hepatic function
- •Topical and phototherapy treatment failure in the past
- •Signed informed consent
排除标准
- •Subject has received prior systemic methotrexate or interferon therapy
- •Unacceptable methotrexate or interferon treatment toxicity in the past
- •Inadequate bone marrow, renal or hepatic function as follows:
- •Bone Marrow: Absolute neutrophil count (ANC) < 1,500/mm 3 (1.5 × 10 9 /L); Platelets <100,000/mm 3 (100 × 10 9 /L); Hemoglobin < 9.0 g/dL (1.4 mmol/L);
- •Renal function: Creatinine >1.5 x Upper limit of normal (ULN)
- •Hepatic function: Aspartate and Alanine transaminase (AST and ALT) >3× ULN; bilirubin > 1.5 × ULN
- •Active hepatitis B or hepatitis C
- •major depression with suicidal ideation or suicide attempt in the past
- •Symptomatic congestive heart failure
- •Epilepsia or other symptomatic central nervous system dysfunction
- •active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
- •Subject is pregnant or lactating
- •Psychiatric illness/social situation that would limit compliance with study requirements
研究组 & 干预措施
Methotrexate arm
Patients assigned to receive methotrexate
干预措施: Methotrexate (Drug)
Interferon Alfa-2b
Patients assigned to receive Interferon alfa 2b
干预措施: Interferon Alfa-2b (Drug)
结局指标
主要结局
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
时间窗: 3 years
Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)
次要结局
- Number of Participants With Adverse Events(3 years)
- Quality of Life as measured by the Dermatology Life Quality Index (DLQI)(3 years)