Status:
UNKNOWN
AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 treatment. In vitro, it has been shown t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00146913
Start Date
March 1 2004
Last Update
April 27 2007
Active Locations (1)
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1
Franck NICOLINI
Lyon, France, 69437