A phase II study of efficacy and safety of Pegasys in patients with Chronic Phase Chronic Myeloid Leukaemia in PCR+ve complete or near complete cytogenetic remission on Glivec at 600 mg daily or maximum tolerated dose (CML07)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes data for 21 patients with newly diagnosed CML Combination of Pegasys and Glivec treatment demographic data diagnostic data treatment data outcome data
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Source Study

Trial acronym

Not available

Trial ID





Phase 2


Commercial sector/Industry,Novartis Australia

Scientific enquiries

Dr Kerry Taylor

Brief Summary

A Phase II study of efficacy and safety of Pegasys® in patients with chronic myeloid leukaemia (CML) in complete or near complete cytogenetic remission but persisting molecular positivity at 600 mg or maximum tolerated dose of Glivec Patients with Ph+ve CML with complete or near complete cytogenetic responses to Glivec® at 600 mg or maximum tolerated dose, but with persisting molecular positivity. Primary Objective: To assess whether adding Pegasys® to Glivec® in these patients improves molecula ....
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Key Inclusion Criteria

All of the following criteria must be met: Cohort One: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved complete cytogenetic response on Glivec® therapy AND not previously in accelerated phase or blast crisis; 4. Sustained complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit ....
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Key Exclusion Criteria

Can healthy volunteers participate?




Sample Size    21

Min. age    0 Not stated

Max. age    0 Not stated

Sex    Both males and females

Condition category    Chronic myeloid leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

To establish whether the addition of the long activing interferon Pegasys is both safe and can improve molecular remission status in CML patients in good remission on Glivec.


Control group Uncontrolled

Comparison not available.


Outcome: To assess whether adding interferon to imatinib in these patients improves molecular response status (by PCR quantification of bcr-abl transcripts)
Timepoint: Measured in 18 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 sponsor ALLG 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. Proposals will be 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