Status:
COMPLETED
Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
Lead Sponsor:
PETHEMA Foundation
Conditions:
Chronic Myeloid Leukaemia
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
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
- 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 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00390897
Start Date
July 1 2003
End Date
December 1 2007
Last Update
November 27 2008
Active Locations (51)
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1
Hospital Ntra. Sra. Sonsoles
Ávila, Avila, Spain
2
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
3
Hospital Clínic
Barcelona, Barcelona, Spain
4
Hospital del Mar
Barcelona, Barcelona, Spain