EUCTR2005-000657-29-SK进行中（未招募）1 期
A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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. Ability to provide written informed consent prior to participation to the study.
- •2. Male or female patients = 18 and = 75 years of age
- •3. Patients within 6 months of diagnosis (date of initial diagnosis is the date of first
- •cytogenetic analysis)
- •4. Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic
- •confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl
- •5. Documented chronic phase CML as defined by:
- •< 15% blasts in peripheral blood and bone marrow
- •< 30% blasts plus promyelocytes in peripheral blood and bone marrow
- •< 20% basophils in the peripheral blood
- •= 100 x 109/L (= 100,000 /mm3) platelets
- •No evidence of extramedullary leukemic involvement, with the exception of
- •hepatospenomegaly
- •6. Adequate end organ function as defined by:
- •total bilirubin < 1.5 x ULN
- •SGOT and SGPT < 2.5 x UNL
- •creatinine < 1.5 x ULN
- •7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug.
- •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. Patients in late chronic phase, accelerated phase, or blastic phase are excluded
- •2. Patients who have received other investigational agents
- •3. Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTIA2107] study immediately prior to the participation in this study
- •4. Patient received any treatment for CML prior to study entry for longer than 1 month with the exception of hydroxyurea and/or anagrelide
- •5. Patients with another primary malignancy except if the other primary malignancy is
- •neither currently clinically significant or requiring active intervention
- •6. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •7. Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,
- •chronic renal disease)
- •8. Patient previously received radiotherapy to = 25% of the bone marrow
- •9. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
- •10. Patients with an ECOG Performance Status Score = 3
- •11. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) >
- •1.5 x IULN, with the exception of patients on treatment with oral anticoagulants
- •12. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
- •13. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- •14. Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
研究者
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