A Phase II study in adult patients with newly diagnosed chronic-phase chronic myeloid leukaemia of initial intensified imatinib therapy and sequential dose-escalation followed by treatment with nilotinib in suboptimal responders to determine the rate and duration of major molecular response (CML09)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 210 patients with newly diagnosed CML, introducing TKI in a sequential and randomised way. Demographic data, diagnostic data, treatment data, outcome data
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Source Study


Commercial sector/Industry,Novartis Australia

Scientific enquiries

Prof Timothy Hughes

Brief Summary

This trial tests the hypothesis that molecular response can be maximised by a combined approach of higher dose imatinib for all de-novo CML patients plus a rapid switch to nilotinib in patients who are intolerant or have suboptimal response to imatinib.

Key Inclusion Criteria

1. Post-pubertal patients who weigh 40kg or over. 2. Newly diagnosed (within six months of study entry) chronic phase, Philadelphia chromosome-positive Chronic Myeloid Leukaemia (Ph+ CML-CP) involving a BCR-ABL transcript known to be quantifiable.3. No prior therapy for CML and no other current anti-leukaemic therapies (other than prior or current treatment with hydroxyurea or anagrelide).4. No signs of extramedullary leukaemia, except for hepatosplenomegaly.5. Documented chronic-phase CML as de ....
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Key Exclusion Criteria

1. Patients who have previously received radiotherapy to >25% of their bone marrow.2. Patients who have undergone major surgery within the 4 weeks prior to study entry or have not recovered from earlier surgery.4 Impaired cardiac function5 Treatment with agents (other than warfarin) that prolong QT interval or inhibit CYP3A4, unless judged to be clinically essential. 6 Patients with international normalized ratio (INR) or activated partial thromboplastin time (APTT) >1.5 x upper limit of normal, ....
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Can healthy volunteers participate?




Sample Size    210

Min. age    15 Years

Max. age    0 Not stated

Sex    Both males and females

Condition category    newly-diagnosed chronic phase chronic myeloid leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

All patients commence imatinib at 600 mg/day. Dose is escalated to 800 mg/day if the trough imatinib plasma level is less than 1000 ng/ml on day 22. Dose is increased to 800 mg/day if the Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) values of BCR-ABL are >10% at 3 months, >1% at 6 months or >0.1% at 12 months. Dose is switched to nilotinib 400 mg/day if a patient is unable to dose escalate to 800 mg after 1 month of trying or if the BCR-ABL value is >10% at 6 months, >1% at 9 months ....
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Control group Uncontrolled



Outcome: To determine the rates of major molecular response (MMR), as determined by RQ-PCR
Timepoint: At 12 and 24 months

Outcome: To estimate the duration of MMR.
Timepoint: At 12 and 24 months

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