TIDEL
ACTRN12607000614493
Treatment
Phase 2
Commercial sector/Industry,Novartis Australia
A/Prof Timothy Hughes
We conducted a trial in 103 de-novo chronic phase CML patients using imatinib 600 mg/day initially, increasing to 800 mg for suboptimal response. Ten patients not achieving major cytogenetic response (MCR) at 6 months and 13 with no complete cytogenetic response (CCR) at 9 months were eligible for dose increase, but this was only possible in 7/23 patients due mainly to non-hematologic toxicities. CCR was achieved in 90% and 95% of patients by 12 and 24 months, compared to rates of 69% and 80% in .... Read more
1.Male or female patients between 16 and 75 years of age inclusive. Patients must have all of the following: 2.i.be enrolled within 6 months of initial diagnosis of CML-CP ii.be previously untreated for CML with the exception of hydroxyurea and/or anagrelide, iii.cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations; OR molecular (PCR) confirmation of bcr-abl gene rearrangement(s); iv.(a) < 15% blasts in peripheral blood and bone marrow; (b) < 30% blasts plus p .... Read more
1.Patients who have received other investigational agents. 2.Patients with secondary chromosomal abnormalities in their CML cells. 3.Patients who received prior chemotherapy. Previous treatment with hydroxyurea is allowed. 4.Patients with uncontrolled medical disease 5.Patients with a positive test for human immunodeficiency virus 6.Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery. 7.Patients who are: (a) pregnant, (b) br .... Read more
No
Sample Size 103
Min. age 16 Years
Max. age 75 Years
Sex Both males and females
Condition category Chronic myeloid leukaemia (CML)
Condition code Cancer
Intervention code Treatment: Drugs
1. All patients receive higher dose imatinib – 600 mg/day 2. in eligible patients dose increased to 800 mg based on time dependent response targets 3. In eligible patients cytosine arabinoside added to imatinib if response targets are not reached
Control group Uncontrolled
Nil
Outcome: To assess overall rates and duration of complete cytogenetic response (CCR) and molecular response (MR) achieved using a schedule of intensive, escalated and combination therapy with Glivec, in association with filgrastim support, in adults with newly-diagnosed chronic-phase CML over the 2 year study period.Timepoint: Every 3 months for 8 years
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