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.(CMLALL01)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes Data for 41 patients with blast phase CML, utilising Glivec and monitoring remission status Demographic data, diagnostic data, treatment data, outcome data
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Chemotherapy |

Source Study

Trial acronym

Not available

Trial ID





Phase 2


Commercial sector/Industry,Novartis Australia

Scientific enquiries

Associate Professor Kenneth Bradstock

Brief Summary

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 ....
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Key Inclusion Criteria

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 ....
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Key Exclusion Criteria

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 ....
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Can healthy volunteers participate?




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 treatment
Timepoint: During the first 2 months of treatment

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

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.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see