Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- 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).
- 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
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 de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario "Germans Trias i Pujol"
🇪🇸Barcelona, Spain
Institut Català d'oncología
🇪🇸Barcelona, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital Ntra. Sra. Sonsoles
🇪🇸Avila, Spain
Hospital comarcal de Valdeorras
🇪🇸O'Barco de Valdeorras, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Clínic
🇪🇸Barcelona, Spain
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Canarias, Spain
Clínica La Concepción
🇪🇸Madrid, Spain
Hospital Ruiz de Alda
🇪🇸Granada, Spain
. Hospital Clínico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Clínica Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Complejo Hospitalario Reina Sofía
🇪🇸Córdoba, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Sant pau
🇪🇸Barcelona, Spain
Hospital vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Médico Quirúrgico Ciudad de Jaén
🇪🇸Jaen, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital general de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Universitario Morales Meseguer, Murcia
🇪🇸Murcia, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Hospital del Río Carrión
🇪🇸Palencia, Spain
Hospital Clínico Universitario
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital General Universitario
🇪🇸Valencia, Spain
Hospital dr. Peset
🇪🇸Valencia, Spain
Hospital de Mataró
🇪🇸Mataró, Barcelona, Spain
Hospital Mútua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Illes balears, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Xeral
🇪🇸Vigo, Spain
Hospital Meixoeiro
🇪🇸Vigo, Spain
Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Hospital General
🇪🇸Segovia, Spain
Hospital Universitario la Fe
🇪🇸Valencia, Spain
Hospital Universitario Princcipe de Asturias
🇪🇸Madrid, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain