Pilot study to determine the efficacy and safety of Glivec (STI571) alone and Glivec (STI571) plus Intron A in the early recovery phase post autologous blood or marrow transplant for advanced phase chronic myeloid leukaemia and Ph-positive acute lymphoblastic leukemia

Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 48 人开始时间: 2005年8月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Patients considered eligible for autologous transplantation by local institutional criteria. 2. Patients with a confirmed diagnosis of Ph chromosome-positive CML not in first chronic phase or Ph chromosome-positive ALL (or patients who are Ph chromosome-negative but BCR/ABL-positive). Patients with chronic phase Ph+ CML with development of resistance to Glivec will also be eligible. Patients with chronic phase CML who are primarily resistant to Glivec will also be eligible. 3. Cryopreserved autologous bone marrow or peripheral blood cells available which contain >2 x 106/L CD34+ cells or an equivalent number of CFU-GM/kg by local institutional criteria. 4. AST (SGOT) and ALT (SGPT) less than or equal to 3x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed. In patients with clinically suspected leukaemic involvement of the liver, AST and ALT less than or equal to 5x the ULN. 5. Total serum bilirubin level less than or equal to 3x the ULN at the laboratory where the analysis was performed. 6. Serum creatinine less than or equal to 1.5 x the upper limit of normal 7. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of study drug. Patients will need to use barrier contraceptive measures throughout the trial 8. Written voluntary informed consent.

发起方

Australasian Leukaemia and Lymphoma Group