A phase II study to determine relapse-free interval after withdrawal of imatinib therapy in adult patients with chronic phase chronic myeloid leukaemia in stable complete molecular remission (CML08)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes Data for 40 patients with newly diagnosed CML Trial followed CML patients, post TKI therapy, in complete remission. Patients were monitored for disease relapse post initial treatment. Demographic data Diagnostic data Treatment data Outcome data
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Source Study




Phase 2


Commercial sector/Industry,Novartis Australia

Scientific enquiries

Dr Dr David Ross

Brief Summary

Following the achievement of deep molecular response on tyrosine kinase inhibitors (TKIs) 54 around half of patients with chronic myeloid leukemia (CML) can discontinue TKI and remain in 55 treatment-free remission (TFR). The ALLG CML8 study commenced in July 2006 and enrolled 40 patients with undetectable BCR-ABL1 mRNA (approximately MR4.5 56 ). Molecular relapse was 57 defined as detectable BCR-ABL1 at any level on two consecutive tests or a single value >0.1%. 58 With a median follow-up of 8. ....
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Key Inclusion Criteria

1. Diagnosis of chronic myeloid leukaemia associated with BCR-ABL quantifiable by RQ-PCR at the time of commencing imatinib therapy 2. Treatment with imatinib for at least 3 years 3. No other current or planned anti-leukaemia therapies 4. Sustained complete molecular response of leukaemia (assessed by undetectable levels of BCR-ABL by RQ-PCR in blood or marrow, for 2 years or longer, tested on at least 2 occasions per year and confirmed by the central PCR laboratory at IMVS using a technique wit ....
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Key Exclusion Criteria

1. Patient has received another investigational agent within last 2 years.2. Currently receiving imatinib treatment as part of a clinical trial (including Extension Phase of IRIS trial)3. Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry.4. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.5. Another primary malignant disease, except those which do not currently require treatment (adequately treated conditions, such as excised skin c ....
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Can healthy volunteers participate?




Sample Size    40

Min. age    18 Years

Max. age    0 Not stated

Sex    Both males and females

Condition category    Chronic phase chronic myeloid leukaemia in stable molecular remission

Condition code    Cancer


Intervention code Treatment: Drugs

This is a non-randomised Phase 2 clinical study. Patients who have achieved a stable complete molecular response on imatinib mesylate treatment (i.e. undetectable BCR-ABL mRNA for at least 2 years) will stop imatinib treatment and be monitored closely for molecular evidence of early relapse. Monitoring off treatment will continue until relapse or for a maximum of 2 years. Patients who relapse will resume imatinib treatment and close monitoring will continue to assess the molecular response to re ....
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Control group Uncontrolled

No comparator.


Outcome: To assess what proportion of CML patients with stable complete molecular response (CMR) on imatinib for at least 2 years remain in complete molecular response (without recurrence of RQ-PCR-detectable BCR-ABL in blood)
Timepoint: For 2 years after ceasing imatinib therapy

Study Protocol: Study protocol,Other
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