Phase II study of nilotinib plus pegylated interferon alfa-2b as first-line therapy in chronic phase chronic myeloid leukaemia aiming to maximize complete molecular response and major molecular response (CML11)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 60 patients with chronic phase CML, utilising nilotinib plus PEGylated interferon alfa-2b Diagnostic data, treatment data, outcome data Cancer Australia demographic data -Year of birth -Aboriginal or Torres Strait Islander status (or Ethnicity)
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Source Study


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

Prof Timothy Hughes

Brief Summary

This study aims to determine the safety and efficacy of treatment with a tyrosine kinase inhibitor (TKI) and pegylated interferon in patients with previously untreated chronic myeloid leukaemia (CML). Who is it for? You may be eligible to join this study if you are aged at least 18 years and have been diagnosed with CML. You must have received no previous treatment for CML. Trial details All participants in this trial will commence treatment with the TKI oral nilotinib alone for 3 months. Provid ....
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Key Inclusion Criteria

1. Post-pubertal male or female patients aged 18 years or above. 2. Newly diagnosed (within six months of study entry) Ph+ CML-chronic phase with a quantifiable BCR-ABL transcript 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 defined by: i. <15% blasts in both the peripheral blood and bone ma ....
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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. 3. Impaired cardiac function, including any of the following: a. Inability to monitor the QT/QTcorrected interval on electrocardiogram (ECG) b. Long QT syndrome or a known family history of long QT syndrome. c. Resting bradycardia (<50 beats per minute) suspected to be secondary to card ....
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Can healthy volunteers participate?




Sample Size    60

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    chronic myeloid leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

Patients will commence taking oral nilotinib at 300mg twice daily for 3 months. After 3 months and if nilotinib therapy is tolerated, pegylated interferon-alpha 2b (PEG IFN) will be introduced at a dose of 30micrograms subcutaneously (sc) per week for 4 weeks, then if tolerated, escalated to 50micrograms sc weekly for the remainder of the study


Control group Uncontrolled



Outcome: To determine the rate of confirmed MR4.5 at 24 months, defined as BCR-ABL quantitative polymerase chain reaction (RQ-PCR) result less than or equal to 0.0032% on 2 successive measurements in patients
Timepoint: 24 months after commencement of trial

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?

• 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