PER-073-00已完成未知
A STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STI571 IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN ACCELERATED PHASE
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2000年1月1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 (or patients who are Ph chromosome negative but Bcr-Abl positive) in accelerated phase defined by the presence of one or more of the following criteria:
- •o Percentage of blasts in blood or bone marrow> 15% but <30%
- •o Percentage of blisters plus promyelocytes in peripheral blood or bone marrow> 30% (as long as <30% of blasts are present in the bone marrow)
- •o Peripheral basophils> 20%
- •o Thrombocytopenia <100 x 10 ^ / L not related to therapy
- •Patients who meet the criteria mentioned above for the accelerated phase of the
- •CML must never have been in blast crisis before the start of study treatment. Patients with accelerated phase CML who are Ph chromosome negative but who are Bcr / Abl-positive are also eligible.
- •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.
- •Patients with an ECOG performance status> 3
- •Serum creatinine levels greater than 2 x the upper normal limit (LTLN) range in the laboratory where the test was performed.
- •Total serum bilirubin> 1.5 x LILN in the laboratory where the analyzes were performed; in patients with clinical suspicion of hepatic leukemic compromise, total bilirubin 3x the range of the upper normal limit (ULN).
- •AST (SGOT) and ALT (SGPT) greater than 3 x the upper normal limit (ULN) range in the laboratory where the analyzes were performed; in patients with clinical suspicion of hepatic leukemic compromise, AST and ALT greater than 5x the range of the upper normal limit (ULN).
- •Patients receiving treatment with interferon-alfa within 48 hours of Day 1.
- •Patients receiving hydroxyurea treatment within 24 hours of Day 1.
- •Patients receiving treatment with homobarringtonine within 14 days of Day 1.
- •Patients receiving treatment with low doses of cytosine arabinoside (<30 mg / m every 12 to 24 hours administered daily) within seven days of Day 1.
- •Patients receiving treatment with moderate doses of cytosine arabinoside (100-200 mg / m3 for 5 to 7 days) within 14 days of Day 1.
- •Patients receiving treatment with high doses of cytosine arabinoside (1-3 g / m each)
- •12 to 24 hours for six to 12 doses) within 28 days of Day 1.
- •Patients receiving anthracyclines, mitoxantrone, etoposide, methotrexate or cyclophosphamide within 21 days of Day 1.
- •Patients receiving busulfan within six weeks of Day 1.
- •Patients receiving antileukemia agents not covered by exclusion criteria 6-12 should not start treatment with STI571 until sufficient time has elapsed for recovery to occur at the nadir of the counts. In practice, a complete recovery may not be possible due to the progression of the underlying disease.
- •Patients who receive any stem cell transplant within six weeks of day 1 or who have not achieved full hematopoietic recovery after transplantation.
- •Patients receiving any other experimental agent within 28 days of Day 1.
- •Patients with grade 3/4 heart disease.
- •Patients with any serious concomitant medical condition.
- •Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
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