Status:
COMPLETED
STI571 ProspectIve RandomIzed Trial: SPIRIT
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Ministry of Health, France
Novartis
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of t...
Detailed Description
Imatinib at 400 mg daily has emerged as the preferred therapy for newly diagnosed CML patients who do not undergo allogeneic stem cell transplant. A phase III randomized study, comparing imatinib at ...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Patients with Bcr-Abl positive CML in chronic phase.
- Patients within 14 weeks of diagnosis and previously untreated for CML except for hydroxyurea and/or anagrelide.
- No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
- ECOG performance score of 0-2
- acceptable hepatic, renal, and cardiac function
- Informed consent signed up
Exclusion
- Depressive syndrome not controlled
- Uncontrolled medical illnesses.
- Women with childbearing potential and male patients who are unwilling or unable to use an adequate method to avoid pregancy for the entire period of the study
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
789 Patients enrolled
Trial Details
Trial ID
NCT00219739
Start Date
September 1 2003
End Date
December 1 2014
Last Update
April 13 2020
Active Locations (1)
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1
University Hospital
Poitiers, France, 86021