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

November 26, 2008 updated by: PETHEMA Foundation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open, prospective, multicentre, phase IV, comparative and randomised study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Avila, Spain
        • Hospital Ntra. Sra. Sonsoles
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Vall d'hebrón
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain
        • Hospital Sant Pau
      • Barcelona, Spain
        • Institut Catala D'oncologia
      • Barcelona, Spain
        • Hospital Universitario "Germans Trias i Pujol"
      • Cáceres, Spain
        • Hospital San Pedro De Alcantara
      • Córdoba, Spain
        • Complejo Hospitalario Reina Sofía
      • Granada, Spain
        • Hospital Ruiz de Alda
      • Huelva, Spain
        • Hospital Juan Ramón Jiménez
      • Jaen, Spain
        • Hospital Médico Quirúrgico Ciudad de Jaén
      • Jerez de la Frontera, Spain
        • Hospital general de Jerez de la Frontera
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Clínico San Carlos de Madrid
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital De Fuenlabrada
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Madrid, Spain
        • Hospital Universitario Princcipe de Asturias
      • Madrid, Spain
        • Clínica La Concepción
      • Murcia, Spain
        • Hospital Universitario Morales Meseguer, Murcia
      • Málaga, Spain
        • Hospital Carlos Haya
      • Málaga, Spain
        • . Hospital Clínico Universitario Virgen de la Victoria
      • O'Barco de Valdeorras, Spain
        • Hospital Comarcal de Valdeorras
      • Palencia, Spain
        • Hospital del Río Carrión
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Segovia, Spain
        • Hospital General
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío
      • Tarragona, Spain
        • Hospital Joan XXIII
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Hospital General Universitario
      • Valencia, Spain
        • Hospital Clinico Universitario
      • Valencia, Spain
        • Hospital Dr. Peset
      • Vigo, Spain
        • Hospital Meixoeiro
      • Vigo, Spain
        • Hospital Xeral
      • Zamora, Spain
        • Hospital Virgen de la Concha
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Barcelona
      • Mataró, Barcelona, Spain
        • Hospital de Mataró
      • Sabadell, Barcelona, Spain
        • Corporacio Sanitaria Parc Tauli
      • Terrassa, Barcelona, Spain
        • Hospital Mútua de Terrassa
    • Canarias
      • Tenerife, Canarias, Spain
        • Hospital Universitario de Canarias
    • Illes balears
      • Palma de Mallorca, Illes balears, Spain
        • Hospital Son Dureta
    • Madrid
      • Alcorcón, Madrid, Spain
        • Hospital de Alcorcón
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain
        • Hospital Son Llatzer
    • Navarra
      • Pamplona, Navarra, Spain
        • Clinica Universitaria de Navarra
      • Pamplona, Navarra, Spain
        • Hospital de Navarra
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PETHEMA Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cervantes Francisco, Dr, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2006

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LMC/PETHEMA
  • 03-0289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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