ACTRN12605000071628
Recruiting
Phase 2
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 sites48 target enrollmentAugust 4, 2005
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced phase chronic myeloid leukaemia
- Sponsor
- Australasian Leukaemia and Lymphoma Group
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
Not specified
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