A Phase II Pilot Study of Glivec (imatinib mesylate formerly known as STI571) Combined with Induction Chemotherapy in Blast-Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, to evaluate safety and improve remission rate.

Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 41 人开始时间: 2005年8月4日最近更新: 2023年10月9日

适应症

试验速览

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•1. Patients with a confirmed diagnosis of Ph+ CML in myeloid or lymphoid blast crisis, defined by the presence of the Philadelphia chromosome or Bcr-Abl fusion transcript and one or both of the following: i) >30% blasts in peripheral blood and/or bone marrow ii) Presence of extramedullary disease other than spleen and/or liver involvement (i.e. chloromas) OR Patients with a confirmed diagnosis of Ph+ ALL 2. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of therapy. Male and female patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of Glivec. 3. Written informed consent.

•1. Exposure to any other investigational agents within 30 days of commencing Glivec 2. Known sensitivity to Glivec or the phenylaminopyrimidine class of drugs 3. ECOG Performance Status Score > 2 (Appendix 1) 4. Left ventricular ejection fraction < 50% on a radionuclide cardiac scan or echocardiogram 5. Creatinine > 1.5 Â´ the upper limit of normal (ULN) at the laboratory where the analysis was performed 6. Serum bilirubin > 2 Â´ ULN 7. AST or ALT > 2.5 Â´ ULN. In patients with suspected leukaemic involvement of the liver, AST or ALT > 5 Â´ ULN. 8. Known HIV seropositivity 9. Any serious concomitant medical condition that could, in the opinion of the Investigator, compromise participation in the study 10. Pregnancy or breastfeeding 11. Dementia, intellectual impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.

发起方

Australasian Leukaemia and Lymphoma Group