TWISTER
ACTRN12606000118505
Treatment
Phase 2
Commercial sector/Industry,Novartis Australia
Dr Dr David Ross
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. .... Read more
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 .... Read more
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 .... Read more
No
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 .... Read more
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
yes
De-identified IPD data for all data collected during the trial
Data available 3 months following publication, for an indefinite period
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.
Any type of analysis. Proposals will be assessed on a case-by-case basis