Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatement. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.

Condition	Intervention	Phase
Chronic Myeloid Leukemia	Drug: Imatinib mesylate 600mg/day  Drug: Peg-Interféron at 90 microg/week	Phase II

Further Study Details: 

Primary Outcomes: Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Secondary Outcomes: Evaluate the tolerance of a combination of STI571 and alpha-interferon
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
• Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
• Male and female * 18 years old.
• Informed consent signed up.
• Performance status grade 0 - 2 (ECOG).
• SGOT and SGPT <3N
• Serum bilirubin < 1.5 N
• Serum creatinine < 1.5 N
• No HSC graft planned
• B-HCG negative for female with potential childbearing

Exclusion Criteria:

• Absence of complete hematologic response
• Extramedullar involvement
• Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
• Depressive syndrome not controlled
• Not controlled dysthyroidy
• Auto-immune pathology not controlled
• Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study
• Significant cardiac disease (grade 3 or more)
• Known seropositivity for HIV
• Active viral hepatitis
• Other malignant disease
• Other experimental medication

Please refer to this study by ClinicalTrials.gov identifier  NCT00146913

Franck NICOLINI, MD      33 472 110 180    franck.nicolini@chu-lyon.fr

France
      Franck NICOLINI, Lyon,  69437,  France; Recruiting

Study chairs or principal investigators

Mauricette MICHALLET, MD,  Principal Investigator,  Hospices Civils de Lyon   

Study ID Numbers:  2003.317
Last Updated:  September 6, 2005
Record first received:  September 5, 2005
ClinicalTrials.gov Identifier:  NCT00146913
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13