PER-034-05未知未知
PHASE II STUDY OF ALEMTUZUMAB (CAMPATH-1H) IN PATIENTS WITH FUNGOID MICOSIS / ADVANCED SEZARY SYNDROME
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1) Histopathological diagnosis of Mycosis Fungoides / Sezary Syndrome.
- •2) Have received up to three treatments with chemotherapy previously.
- •3) Patient> of 18 years.
- •4) You may have previously received radiation therapy.
- •5) Transaminase and alkaline phosphatase values not higher than double the maximum limit value of normality bilirubin <2 mg / dL.
- •6) Adequate bone marrow reserve: Hemoglobin> 10mg / dl, neutrophils> 1,500 mm3.
- •7) Platelets> 100,000 mm3.
- •8) EC0G <2.
排除标准
- •1) Clinical stage I.
- •2) Age> 75 years.
- •3) Creatinine clearance less than 50cc / ml.
- •4) ECOG equal to or greater than 3.
- •5) Active infection.
- •6) Pregnancy, lactation.
- •7) HIV positive.
- •8) Patient with Mycosis Fungoide / Sezary Syndrome with transformation.
- •9) Renal insufficiency.
- •10) Hepatic insufficiency.
- •11) Psychiatric disorder.
- •12) Carrier of a second neoplasm.
- •13) Female patients of childbearing age, with positive pregnancy test.
- •14) Serology HTLV-1/2 positive.
- •15) Have received chemotherapy within one month of inclusion in the study.
- •16) History of myocardial infarction, congestive heart failure or dilated cardiomyopathy.
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