Imatinib Mesylate and Combination Chemotherapy With or Without a Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Gleevec (Imatinib) Plus Multi-Agent Chemotherapy For Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Imatinib mesylate may also stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which treatment regimen is most effective in treating acute lymphoblastic leukemia.
PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate together with combination chemotherapy with or without a donor stem cell transplant and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.
研究概览
地位
条件
详细说明
OBJECTIVES:
Primary
- To determine the clinical efficacy of imatinib mesylate and combination chemotherapy in terms of complete response (CR) rate (both hematologic and molecular), CR duration, and overall survival in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
- To determine the toxicities of this regimen in these patients.
Secondary
- To establish the prognostic factors in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to age (64 or less vs 65 or over).
- Induction chemotherapy: Patients receive daunorubicin hydrochloride IV continuously over 24 hours on days 1-3, vincristine IV on days 1 and 8, and oral prednisolone on days 1-14. Treatment repeats for 5 courses in the absence of disease progression or unacceptable toxicity.
- Imatinib mesylate administration: Patients also receive oral imatinib mesylate once daily beginning on day 8 of course 1 induction chemotherapy and continuing for up to 2 years.
- Consolidation chemotherapy: Patients receive daunorubicin hydrochloride IV continuously over 24 hours on days 1-2, vincristine IV on days 1 and 8, and oral prednisolone on days 1-14 in course 1; cytarabine IV over 2 hours and etoposide IV over 3 hours on days 1-4 in courses 2 and 4; and methotrexate IV continuously over 36 hours on days 1-2 and 15-16 and leucovorin calcium IV every 6 hours x 3 doses followed by oral leucovorin calcium until methotrexate levels are < 0.05 micromol/L in courses 3 and 5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with available HLA-matched sibling or unrelated hematopoietic cell donors or HLA-nonidentical familial hematopoietic cell donors proceed to allogeneic hematopoietic stem cell transplantation (HSCT). Patients who are without hematopoietic cell donors and who remain in hematologic remission continue to receive maintenance therapy with oral imatinib mesylate.
- Allogeneic HSCT: Patients undergo HSCT.
- CNS prophylaxis: Patients receive six doses of intrathecal (IT) methotrexate and hydrocortisone beginning on the first day of each chemotherapy course. Patients with CNS disease at diagnosis receive intensified CNS therapy comprising 10 doses of IT methotrexate and cranial irradiation after bone marrow remission is achieved.
After completion of study treatment, patients are followed periodically.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Seoul、大韩民国、138-736
- Asan Medical Center - University of Ulsan College of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Acute lymphoblastic leukemia (ALL) or acute mixed lineage leukemia
- Newly diagnosed disease
Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia or Ph+ acute mixed lineage leukemia
- Positive result for RT-PCR for Bcr-Abl transcript (Ph+ ALL or Philadelphia-chromosome positive acute mixed lineage leukemia)
PATIENT CHARACTERISTICS:
- Bilirubin < 2 mg/dL
- SGOT < 3 times upper limit of normal
- Creatinine < 2.0 mg/dL
- Ejection fraction > 45% by MUGA scan
- Not nursing
- Fertile patients must use effective contraception
- No known sensitivity to study drugs
- No severe medical conditions that, in the view of the investigator, prohibits participation in the study
PRIOR CONCURRENT THERAPY:
- No other investigational agents in the past 30 days
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Proportion of patients achieving hematologic and molecular complete response (CR) after induction chemotherapy and imatinib mesylate
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Duration of hematologic CR
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Durations of hematologic and molecular CR after hematopoietic stem cell transplantation
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次要结果测量
结果测量 |
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总生存期
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Clinical toxicities
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Prognostic factors in patients treated with this regimen
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 白血病
- 前体细胞淋巴细胞白血病-淋巴瘤
- 白血病、淋巴细胞
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 抗病毒药物
- 核酸合成抑制剂
- 酶抑制剂
- 抗炎药
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 微管蛋白调节剂
- 抗有丝分裂剂
- 有丝分裂调节剂
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药,激素
- 保护剂
- 抗肿瘤药,植物性
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 皮肤病药物
- 微量元素
- 蛋白激酶抑制剂
- 抗生素、抗肿瘤药
- 维生素
- 生殖控制剂
- 解毒剂
- 复合维生素B
- 堕胎药,非甾体
- 堕胎剂
- 叶酸拮抗剂
- 泼尼松龙
- 依托泊甙
- 亚叶酸
- 左旋叶酸
- 阿糖胞苷
- 甲氨蝶呤
- 长春新碱
- 柔红霉素
- 甲磺酸伊马替尼
- 氢化可的松
- 氢化可的松 17-丁酸 21-丙酸
- 醋酸氢化可的松
- 氢化可的松半琥珀酸酯
其他研究编号
- CDR0000586176
- AMC-UUCM-2005-0238
- NOVARTIS-AMC-UUCM-2005-0238
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