Chronic Myeloid Leukaemia
Conditions
Keywords
chronic myeloid leukaemia, Glivec, Interferon
Brief summary
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses
Detailed description
Open, prospective, multicentre, phase IV, comparative and randomised study
Interventions
DRUGGlivec
DRUGInterferon
Sponsors
PETHEMA Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly-diagnosed chronic-phase Ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such). 2. Age between 18 and 72 years (both included). 3. Performance status \< 2 on the ECOG scale (see Annex 3). 4. Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
Exclusion criteria
1. Criteria of acceleration or blastic crisis (see Annex 7). 2. When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy. 3. Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted). 4. Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine \> 1.5 times the upper limit of normality). 5. Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15). 6. Positive serology for HIV. 7. Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ). 8. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The fundamental objective of this study is to compare the therapeutic efficacy of Glivec® given in monotherapy (providing for dose scaling according to the response obtained at different periods of time from the beginning) in combination with standard in | — |
| The median survival of patients with CML is close to 7 years. | — |
| One year and a half after diagnosis, the rate of progression to the acceleration phase and blastic crisis is very low (3.3%) in patients treated with Glivec® as first line. | — |
| With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival. | — |
| Therefore, taking into account that the rate of complete cytogenetic responses to Glivec® in newly-diagnosed CML is 76% after 18 months of treatment (see table I), the fundamental objective of the study will be to compare the rate of complete cytogenetic | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival (analysed according to intention to treat) | — |
| Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat) | — |
| Haematological and non haematological tolerance and safety | — |
| The time until complete cytogenetic responses are obtained | — |
| Rate of major cytogenetic responses | — |
| Rate of molecular responses | — |
| Time to the loss of cytogenetic, haematological or molecular response | — |
Countries
Spain
Outcome results
None listed