Therapy of Late Chronic Phase Chronic Myelogenous Leukemia (CML) With High-Dose Gleevec (STI571)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Cytogenetic Complete Response (CR) Rate
研究概览
简要总结
Objectives:
Primary endpoints:
To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML using initial higher dose Gleevec therapy.
Secondary endpoints:
To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival.
To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
详细描述
Treatment: Imatinib mesylate is a new oral medication that blocks a protein that is responsible for CML
Patients on this study will take 400 mg of imatinib twice daily (morning and evening). If you have side effects, the dose may be lowered. If you are taking less than 800 mg of imatinib, you can take your dose once per day or divided in two doses. Imatinib mesylate should be taken with a large glass of water.
After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated. Treatment may be continued for up to 20 years, or as long as it is judged best to control the leukemia.
Update June 2010:
Blood tests are recommended 2 times per year. Your doctor will discuss with you how often you should have blood tests. Bone marrow will be done if your doctor thinks it is necessary to check your disease. You must return to M. D. Anderson at least once every year. You may not need a bone marrow test every visit, but you will have blood drawn to measure the amount of disease you have. If the leukemia cannot be found for 2 years or longer on the blood test called PCR which is done to measure the amount of disease you have, your doctor may talk to you about stopping treatment with imatinib. If you and your doctor decide to stop your therapy, you will have a blood test for PCR done every 3 to 6 months. You do not need to return to M. D. Anderson to have this blood test done. You may have the blood taken by your local doctor and mailed to M. D. Anderson. If the leukemia is found again by the PCR blood test, your doctor may recommend that you restart treatment with imatinib. You may decide to stay on treatment with imatinib even if your PCR blood test does not show any sign of leukemia for 2 years or longer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 15 years or older with a diagnosis of Ph-positive or Bcr-positive CML in chronic phase CML. They should be in at least one of the categories below: A. Patients must have received interferon alpha and: - Failed to achieve or lost a hematologic complete remission(after 3 months of therapy with interferon), or - Failed to achieve or lost a major cytogenetic remission, or - Failed to achieve or lost a complete molecular remission (competitive quantitative PCR <0.05%), or - Were intolerant to interferon B. Patients in late chronic phase (i.e., >/= 12 months from diagnosis) who have not received treatment with interferon and: - Have high risk for toxicity with IFN-A (e.g., age >/= 60 years), or - Refuse to use IFN-A
- •ECOG performance of 0-
- •Serum bilirubin less than 2mg%, serum creatinine less than 2mg%.
排除标准
- •NYHA Class 3-4 heart disease; Pregnant or lactating females
- •Women of pregnancy potential must practice contraception
- •Patients in accelerated phase (except clonal evolution) or blastic phase are excluded. - Patients with clonal evolution as their only criterion for accelerated phase are eligible.
- •Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the CML population.
研究组 & 干预措施
Gleevec
Gleevec 400 mg by mouth (P.O.) twice daily = 800 mg total daily dose
干预措施: Gleevec (Drug)
结局指标
主要结局
Cytogenetic Complete Response (CR) Rate
时间窗: Evaluated at 6 months; Polymerase Chain Reaction (PCR) testing for BCR-ABL every 3-4 months in year one then every year.
CR Rate = Number participants out of total treated with complete cytogenetic response. Complete Hematologic Remission (CHR) - normalization \>4 weeks of bone marrow (less than 5% blasts) \& peripheral blood with white blood count (WBC)\<10x10\^9/L \& no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs \& symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \<50% of pretreatment, or thrombocytosis \>450x10\^9/L but \<50% of pretreatment. Complete hematologic remission further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or fluorescence in situ hybridization (FISH): a) No cytogenetic response - Ph positive 100% of pretreatment value; b) Minor cytogenetic response - Ph positive 35-90% of pretreatment value; c) Partial cytogenetic response - Ph positive 1-34% of pretreatment value; d) Complete cytogenetic response - Ph positive 0%.
次要结局
未报告次要终点