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

Phase 4

Completed

• Conditions: Chronic Myeloid Leukaemia

• Registration Number: NCT00390897
• Lead Sponsor: PETHEMA Foundation

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

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-10
• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-23
• Study Completion: 2007-12
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-26
• Last Update Posted: 2008-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (51)

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Canarias, Spain

Hospital Son Dureta; 🇪🇸 Palma de Mallorca, Illes balears, Spain

Hospital de Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Mallorca, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarra, Spain

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