CTRI/2011/091/000249已完成4 期
A prospective, open label, non-comparative, non randomized, multi- centric study to evaluate the efficacy and safety of Imatinib in patients with newly diagnosed and previously untreated BCR-ABL positive Chronic Myelogenous Leukemia Chronic Phase (CML- CP).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Provided IEC/IRB approved written informed consent
- •2.Newly diagnosed and previously untreated BCR-ABL positive CML.
- •3.Hematological and molecular diagnosis of BCR-ABL positive CML.
- •4.Must be in chronic phase (CP) ( all five criteria must be fulfilled )
- •i.Less than 15% blasts in peripheral blood and bone marrow
- •ii.Less than 30% blasts + promyelocytes in peripheral blood or bone marrow
- •iii.Less than 20% basophils in peripheral blood
- •iv.Greater than 100 x 109/L platelets
- •v.No extramedullary involvement other than spleen or liver
- •5.ECOG Performance Scale of Less than or equal to 2
- •6.Life expectancy greater than 12 months as determined by the Investigator
排除标准
- •1. Patients with BCR-ABL negative CML.
- •2. Patients who are in CML-accelerated phase (CML-AP) or CML-blast phase (CML-BP) during initial presentation.
- •3. Patients with severe renal and hepatic impairment. (creatine 2mgs/dl; liver enzymes and bilirubin 2.5 times ULN ; alkaline phosphatase 1.5 times ULN
- •4. Patients with congestive cardiac failure.
- •5. Patients who are HIV positive
- •6. Patients who have a tendency of fluid retention and edema
- •7. Patient who are on other concurrent anti cancer agents.
- •8. Pregnant and lactating women
- •9. Women of child bearing potential not using contraceptives
- •10. Patients on drugs which induce/inhibit CYP3A metabolism,CYP2D6 metabolism
- •11. Patients have been on any Investigational medicine within 30 days from screening
- •12. Any condition that, in the opinion of the investigator, does not justify the patients inclusion with the study
研究者
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