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

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

360

Phase

  • 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'Hebron
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Sant Pau
      • Barcelona, Spain
        • Institut Català 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 Ramón 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 Clínico 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 Mutua 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

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

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

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

PETHEMA Foundation

Investigators

  • 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

July 1, 2003

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 20, 2006

First Posted (ESTIMATE)

October 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2008

Last Update Submitted That Met QC Criteria

November 26, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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