None listed
Conditions
Interventions
This study evaluates the addition of Glivec (Imatinib) at variable time points in the first weeks to months post autologous stem cell transplant to evaluate safety and efficacy in the treatment of Philadelphia chromosome positive leukemia.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed