Pinnacle, ALLG CML11
ACTRN12612000851864
Treatment
Phase 2
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group
Prof Timothy Hughes
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 .... Read more
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 .... Read more
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 .... Read more
No
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
nil
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 patientsTimepoint: 24 months after commencement of trial
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
• 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.
Any type of analysis Assessed on a case-by-case basis