TIDEL II
ACTRN12607000325404
Treatment
Phase 2
Commercial sector/Industry,Novartis Australia
Prof Timothy Hughes
This trial tests the hypothesis that molecular response can be maximised by a combined approach of higher dose imatinib for all de-novo CML patients plus a rapid switch to nilotinib in patients who are intolerant or have suboptimal response to imatinib.
1. Post-pubertal patients who weigh 40kg or over. 2. Newly diagnosed (within six months of study entry) chronic phase, Philadelphia chromosome-positive Chronic Myeloid Leukaemia (Ph+ CML-CP) involving a BCR-ABL transcript known to be quantifiable.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 de .... 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.4 Impaired cardiac function5 Treatment with agents (other than warfarin) that prolong QT interval or inhibit CYP3A4, unless judged to be clinically essential. 6 Patients with international normalized ratio (INR) or activated partial thromboplastin time (APTT) >1.5 x upper limit of normal, .... Read more
No
Sample Size 210
Min. age 15 Years
Max. age 0 Not stated
Sex Both males and females
Condition category newly-diagnosed chronic phase chronic myeloid leukaemia
Condition code Cancer
Intervention code Treatment: Drugs
All patients commence imatinib at 600 mg/day. Dose is escalated to 800 mg/day if the trough imatinib plasma level is less than 1000 ng/ml on day 22. Dose is increased to 800 mg/day if the Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) values of BCR-ABL are >10% at 3 months, >1% at 6 months or >0.1% at 12 months. Dose is switched to nilotinib 400 mg/day if a patient is unable to dose escalate to 800 mg after 1 month of trying or if the BCR-ABL value is >10% at 6 months, >1% at 9 months .... Read more
Control group Uncontrolled
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Outcome: To determine the rates of major molecular response (MMR), as determined by RQ-PCRTimepoint: At 12 and 24 months
Outcome: To estimate the duration of MMR.Timepoint: At 12 and 24 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 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