Clinical trial NCT00390897: Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myeloid Leukaemia
Keywords: chronic myeloid leukaemia
Glivec
Interferon
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: The median survival of patients with CML is close to 7 years.
measure: 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.
measure: With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival.
measure: 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 outcomes:
measure: The time until complete cytogenetic responses are obtained
measure: Rate of major cytogenetic responses
measure: Rate of molecular responses
measure: Time to the loss of cytogenetic, haematological or molecular response
measure: Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat)
measure: Survival (analysed according to intention to treat)
measure: Haematological and non haematological tolerance and safety
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrassa
state: Barcelona
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Illes balears
city: Alcorcón
country: Spain
facility: Hospital de Alcorcón
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Mallorca
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Avila
country: Spain
facility: Hospital Ntra. Sra. Sonsoles
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant pau
city: Barcelona
country: Spain
facility: Hospital Universitario "Germans Trias i Pujol"
city: Barcelona
country: Spain
facility: Hospital vall d'Hebrón
city: Barcelona
country: Spain
facility: Institut Català d'oncología
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Complejo Hospitalario Reina Sofía
city: Granada
country: Spain
facility: Hospital Ruiz de Alda
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Jaen
country: Spain
facility: Hospital Médico Quirúrgico Ciudad de Jaén
city: Jerez de la Frontera
country: Spain
facility: Hospital general de Jerez de la Frontera
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Clínica La Concepción
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Princcipe de Asturias
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer, Murcia
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: O'Barco de Valdeorras
country: Spain
facility: Hospital comarcal de Valdeorras
city: Palencia
country: Spain
facility: Hospital del Río Carrión
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Segovia
country: Spain
facility: Hospital General
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
city: Valencia
country: Spain
facility: Hospital dr. Peset
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Valencia
country: Spain
facility: Hospital Universitario la Fe
city: Vigo
country: Spain
facility: Hospital Meixoeiro
city: Vigo
country: Spain
facility: Hospital Xeral
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Cervantes Francisco, Dr
role: STUDY_CHAIR
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