EUCTR2004-002517-36-AT进行中（未招募）不适用
A Phase II Study of BMS-354825 in Subjects with Lymphoid Blast Phase ChronicMyeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib MesylateProtocol version 1.0 dated 2004-10-05, andAmendment 01 country specific version 1.0 dated 2005-03-14
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Subjects with Ph+ (or BCR/ABL+) lymphoid blast phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- •Subjects are considered to have lymphoid blast phase CML if they meet at least one of the following criteria:
- •30% lymphoid blasts in peripheral blood or bone marrow
- •Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with peripheral blood lymphoid blast morphology.
- •Subjects with pH + ALL who experience progression or lack of response after both standard induction or consolidation chemotherapy plus imatinib at a dose of > 600 mg/day ( or 400mg/day to < 600 mg/day if the subject is intolerant of 600 mg/day) after 4 weeks.
- •2)ECOG performance status score 0 - 2 (See Appendix 1)
- •3)Adequate hepatic function defined as:
- •total bilirubin < or equal to 2.0 times the institutional upper limit of normal
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < or equal to 2.5 times the institutional upper limit of normal
- •4)Adequate renal function defined as:
- •serum creatinine < or equal to 1.5 times the institutional upper normal limit
- •5)Serum potassium and magnesium levels within institutional normal limits. Total
- •serum calcium or ionized calcium level must be greater than or equal to the lower
- •limit of normal.
- •6)Men and women, 18 years of age or older.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Women who are pregnant or breastfeeding.
- •2) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
- •3) Subjects who are eligible and willing to undergo transplantation during the screening period.
- •4) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •5) Uncontrolled or significant cardiovascular disease
- •6) Subjects who received:
- •- imatinib mesylate within 7 days
- •- interferon or cytarabine within 14 days
- •- a targeted small molecule anti-cancer agent within 14 days,
- •- any other investigational or antineoplastic agent other than hydroxyurea within 28 days before starting treatment with BMS-354825
- •7) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
- •8) Subjects taking medications that irreversibly inhibit platelet function
- •9) Prior therapy with BMS-354825.
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