NCT00101595已完成2 期
A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Major and overall hematologic response rates
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects with Philadelphia chromosome positive (Ph+) (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 who 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.
- •ECOG performance status score 0-
- •Adequate hepatic function defined as: *Total bilirubin less than or equal to 2.0 times the institutional upper limit of normal; *alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times the institutional upper limit of normal.
- •Adequate renal function defined as: *serum creatinine less than or equal to 1.5 times the institutional upper normal limit.
- •Men and women, 18 years of age or older.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IC/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
排除标准
- •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.
- •WOCBP using a prohibited contraceptive method (not applicable).
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.
- •Subjects who are eligible and willing to undergo transplantation during the screening period.
- •A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •Demential or altered mental status that would prohibit the understanding or rendering of informed consent.
- •History of significant bleeding disorder unrelated to CML.
- •Concurrent incurable malignancy other than CML.
- •Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
- •Subjects who received any of the following:
- •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 or anagrelide within 28 days before starting treatment with BMS-
- •Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes.
- •Subjects taking medications that irreversibly inhibit platelet function.
- •Prior therapy with BMS-
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
研究组 & 干预措施
1
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Major and overall hematologic response rates
时间窗: throughout the study
次要结局
- Durability of hematologic response and time to hematologic response (major and overall)(throughout the study)
- Assess cytogenetic and molecular responses(throughout the study)
- Measure minor hematologic response rate in the imatinib resistant group(throughout the study)
- Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene(throughout the study)
- Measure the heath-related QOL using FACT-G(throughout the study)
- To assess safety and tolerability of dasatinib(throughout the study)
- Population PK(first month)
研究者
研究点 (1)
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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 MesylateRevised Protocol 01: Incorporates Amendment 03 and Administrative Letter 01, andAmendment 01 country specific version 1.0 dated 2005-03-14ympohid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (ALL)EUCTR2004-002517-36-DEBristol-Myers Squibb International Corporation256