Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia

Study Overview
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Brief Summary
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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
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Open, prospective, multicentre, phase IV, comparative and randomised study

Official Title
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Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia

Conditions
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Chronic Myeloid Leukaemia

Intervention / Treatment
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* Drug: Glivec
* Drug: Interferon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Age between 18 and 72 years (both included). Performance status < 2 on the ECOG scale (see Annex 3). Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6). Exclusion Criteria: Criteria of acceleration or blastic crisis (see Annex 7). 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. Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted). Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine > 1.5 times the upper limit of normality). 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). Positive serology for HIV. Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ). Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glivec|nan|
|Drug: Interferon|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat) |  |  | 
| Survival (analysed according to intention to treat) |  |  | 
| Haematological and non haematological tolerance and safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic myeloid leukaemia, Glivec, Interferon