PER-004-01已完成未知
A STUDY TO DETERMINE THE SAFETY AND EFFICACY OF STI571 IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA THAT ARE HEMATOLOGICALLY OR CYGOGENICALLY RESISTANT OR REFRACTORY OR INTOLERANT TO THE ALPHA INTERFERO
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2001年1月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •Men and women> 18 years of age.
- •Patients with confirmed diagnosis of CML positive Ph chromosome in chronic phase
- •Patients must have refractivity or documented resistance to an interferon alpha defined as one of the following postulates:
- •o Hematological resistance: failure to achieve a complete hematological response, lasting at least one month despite 6 or more months of a treatment regimen containing interferon alfa (at least 25 million international units (MIU) per week) .
- •o Cytogenetic resistance: Cytogeny of the bone marrow with> 65% of Ph positive chromosome, after at least one year of therapy based on interferon alfa.
- •o Cytogenetic refractoriness: An increase in the Ph positive chromosome cells of the bone marrow of at least 30 percentage points (for example, from 20% to 50%, or from 30% to 60%) confined by two samples with at least one month of difference, or an increase> 65%
- •o Hematologic refractoriness - A rising white blood cell count (> 100% increase and up to a level> 20 x 10 9 / L confirmed by two samples at least two weeks apart) while receiving a regimen containing interferon alpha (at least 25 MIU) per week).
- •Patients who have shown intolerance to interferon alpha therapy defined as: Grade> 3 documented non-haematological toxicity, persistent for more than one month in a patient receiving a regimen containing interferon alfa. Patients who are intolerant to interferon alfa should be diagnosed more than three months.
- •Written informed consent given voluntarily
排除标准
- •Patients with the ability to procreate without a negative pregnancy test prior to the beginning of the ingestion of experimental medication. Physical barrier contraceptive measures should be used in both sexes throughout the study.
- •Serum creatinine and bilirubin concentrations greater than twice the upper limit of the normal range.
- •SGOT (AST) and SGPT (ALT) greater than twice the upper limit of the normal range.
- •Percent blasts or basophils in peripheral blood or bone marrow> 15%.
- •Percentage of blisters plus promyelocytes in peripheral blood or bone marrow> 30%.
- •Patients with platelet count <100x10VL.
- •Patients with an ECOG Performance Status> 3.
- •Patients receiving busulfan within 6 weeks of Visit 1.
- •Patients receiving treatment with interferon-alpha within 14 days of Visit l.
- •Patients receiving treatment with cytosine arbinoside within 14 days of Visit 1.
- •Patients receiving hydroxyurea treatment within 7 days of Visit 1.
- •Patients who have received other experimental agents within 28 days of the Visit
- •Patients with cardiac problems Grade 3/4 defined according to the criteria of the New York Heart Association.
- •Patients with a history of non-compliance with medical regimens or who are considered potentially untrustworthy.
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