Not available
ACTRN12605000072617
Treatment
Phase 2
Commercial sector/Industry,Novartis Australia
Associate Professor Kenneth Bradstock
Primary Objective: Investigation of the safety and tolerability of Glivec in combination with induction chemotherapy for blast-phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia Secondary Objective(s): (1) Investigation of the efficacy of Glivec combined with induction chemotherapy in Ph+ acute leukaemias (2) Biochemical evaluation of Abl kinase suppression by Glivec in leukaemic blasts Patients aged 16-70 with CML in blast crisis or Ph+ ALL All pati .... Read more
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 initi .... Read more
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 ´ the upper limit of normal (ULN) at the laboratory where the analysis was performed 6. Serum bilirubin > 2 ´ ULN 7. AST or ALT > 2.5 ´ ULN. In patients with suspected leukaem .... Read more
No
Sample Size 41
Min. age 16 Years
Max. age 70 Years
Sex Both males and females
Condition category Blast-Phase Chronic Myeloid Leukemia , Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Condition code Cancer
Intervention code Treatment: Drugs
Combined therapy with Glivec for Philadelphia-chromosome positive leukemias.
Control group Uncontrolled
Conventional chemotherapy for Philadelphia-chromosome positive leukemias.
Outcome: To determine the safety and tolerability of Glivec (STI571) at 600 mg daily in combination with induction chemotherapy in adult patients with CML in blast crisis or Ph+ ALL during the first 2 months of treatmentTimepoint: During the first 2 months of treatment
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis