Back to resultsGlivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
Primary Purpose
Chronic Myeloid Leukaemia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Glivec
Interferon
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukaemia focused on measuring chronic myeloid leukaemia, Glivec, Interferon
Eligibility Criteria
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
Sites / Locations
- Hospital Central de Asturias
- Hospital de Mataró
- Corporació Sanitària Parc Taulí
- Hospital Mútua de Terrassa
- Hospital Universitario de Canarias
- Hospital Son Dureta
- Hospital de Alcorcón
- Hospital Son Llatzer
- Clínica Universitaria de Navarra
- Hospital de Navarra
- Hospital Verge de la Cinta
- Hospital Ntra. Sra. Sonsoles
- Hospital Clínic
- Hospital del Mar
- Hospital Sant pau
- Hospital Universitario "Germans Trias i Pujol"
- Hospital vall d'Hebrón
- Institut Català d'oncología
- Hospital San Pedro de Alcántara
- Complejo Hospitalario Reina Sofía
- Hospital Ruiz de Alda
- Hospital Juan Ramón Jiménez
- Hospital Médico Quirúrgico Ciudad de Jaén
- Hospital general de Jerez de la Frontera
- Hospital Juan Canalejo
- Hospital Arnau de Vilanova
- Clínica La Concepción
- Clínica Puerta de Hierro
- Hospital Clínico San Carlos de Madrid
- Hospital de Fuenlabrada
- Hospital Doce de Octubre
- Hospital Gregorio Marañón
- Hospital Ramón y Cajal
- Hospital Universitario Princcipe de Asturias
- Hospital Universitario Morales Meseguer, Murcia
- . Hospital Clínico Universitario Virgen de la Victoria
- Hospital Carlos Haya
- Hospital comarcal de Valdeorras
- Hospital del Río Carrión
- Hospital Clínico Universitario de Salamanca
- Hospital Universitario Marqués de Valdecilla
- Hospital General
- Hospital Universitario Virgen del Rocío
- Hospital Joan XXIII
- Hospital Clínico Universitario
- Hospital dr. Peset
- Hospital General Universitario
- Hospital Universitario la Fe
- Hospital Meixoeiro
- Hospital Xeral
- Hospital Virgen de la Concha
Outcomes
Primary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390897
Brief Title
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
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukaemia
Keywords
chronic myeloid leukaemia, Glivec, Interferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glivec
Intervention Type
Drug
Intervention Name(s)
Interferon
Primary Outcome Measure Information:
Title
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
Title
The median survival of patients with CML is close to 7 years.
Title
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.
Title
With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival.
Title
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 Measure Information:
Title
The time until complete cytogenetic responses are obtained
Title
Rate of major cytogenetic responses
Title
Rate of molecular responses
Title
Time to the loss of cytogenetic, haematological or molecular response
Title
Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat)
Title
Survival (analysed according to intention to treat)
Title
Haematological and non haematological tolerance and safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cervantes Francisco, Dr
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Mútua de Terrassa
City
Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Canarias
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
State/Province
Illes balears
Country
Spain
Facility Name
Hospital de Alcorcón
City
Alcorcón
State/Province
Madrid
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Mallorca
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital Verge de la Cinta
City
Tortosa
State/Province
Tarragona
Country
Spain
Facility Name
Hospital Ntra. Sra. Sonsoles
City
Avila
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Sant pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario "Germans Trias i Pujol"
City
Barcelona
Country
Spain
Facility Name
Hospital vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Institut Català d'oncología
City
Barcelona
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
Country
Spain
Facility Name
Complejo Hospitalario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Ruiz de Alda
City
Granada
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Hospital Médico Quirúrgico Ciudad de Jaén
City
Jaen
Country
Spain
Facility Name
Hospital general de Jerez de la Frontera
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Clínica La Concepción
City
Madrid
Country
Spain
Facility Name
Clínica Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
Country
Spain
Facility Name
Hospital de Fuenlabrada
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Princcipe de Asturias
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer, Murcia
City
Murcia
Country
Spain
Facility Name
. Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital comarcal de Valdeorras
City
O'Barco de Valdeorras
Country
Spain
Facility Name
Hospital del Río Carrión
City
Palencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital General
City
Segovia
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Valencia
Country
Spain
Facility Name
Hospital dr. Peset
City
Valencia
Country
Spain
Facility Name
Hospital General Universitario
City
Valencia
Country
Spain
Facility Name
Hospital Universitario la Fe
City
Valencia
Country
Spain
Facility Name
Hospital Meixoeiro
City
Vigo
Country
Spain
Facility Name
Hospital Xeral
City
Vigo
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
12. IPD Sharing Statement
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
Learn more about this trial
Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
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