Not available
ACTRN12605000041651
Treatment
Phase 2
Commercial sector/Industry,Novartis Australia
Dr Kerry Taylor
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 .... Read more
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 .... Read more
No
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
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