A Phase II study in adult patients with newly-diagnosed chronic myeloid leukaemia of initial intensified Glivec® therapy, and sequential combination therapy for non-responders, in order to assess response and survival (CML06)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes Data for data for 103 patients with newly diagnosed CML Trial is a single arm treatment of Glivec for all patients, with monitoring of disease response Dataset includes demographic data, diagnostic, treatment data, outcome data
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Source Study


Commercial sector/Industry,Novartis Australia

Scientific enquiries

A/Prof Timothy Hughes

Brief Summary

We conducted a trial in 103 de-novo chronic phase CML patients using imatinib 600 mg/day initially, increasing to 800 mg for suboptimal response. Ten patients not achieving major cytogenetic response (MCR) at 6 months and 13 with no complete cytogenetic response (CCR) at 9 months were eligible for dose increase, but this was only possible in 7/23 patients due mainly to non-hematologic toxicities. CCR was achieved in 90% and 95% of patients by 12 and 24 months, compared to rates of 69% and 80% in ....
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Key Inclusion Criteria

1.Male or female patients between 16 and 75 years of age inclusive. Patients must have all of the following: enrolled within 6 months of initial diagnosis of CML-CP previously untreated for CML with the exception of hydroxyurea and/or anagrelide, iii.cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations; OR molecular (PCR) confirmation of bcr-abl gene rearrangement(s); iv.(a) < 15% blasts in peripheral blood and bone marrow; (b) < 30% blasts plus p ....
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Key Exclusion Criteria

1.Patients who have received other investigational agents. 2.Patients with secondary chromosomal abnormalities in their CML cells. 3.Patients who received prior chemotherapy. Previous treatment with hydroxyurea is allowed. 4.Patients with uncontrolled medical disease 5.Patients with a positive test for human immunodeficiency virus 6.Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery. 7.Patients who are: (a) pregnant, (b) br ....
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Can healthy volunteers participate?




Sample Size    103

Min. age    16 Years

Max. age    75 Years

Sex    Both males and females

Condition category    Chronic myeloid leukaemia (CML)

Condition code    Cancer


Intervention code Treatment: Drugs

1. All patients receive higher dose imatinib – 600 mg/day 2. in eligible patients dose increased to 800 mg based on time dependent response targets 3. In eligible patients cytosine arabinoside added to imatinib if response targets are not reached


Control group Uncontrolled



Outcome: To assess overall rates and duration of complete cytogenetic response (CCR) and molecular response (MR) achieved using a schedule of intensive, escalated and combination therapy with Glivec, in association with filgrastim support, in adults with newly-diagnosed chronic-phase CML over the 2 year study period.
Timepoint: Every 3 months for 8 years

Study Protocol: Not Available
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