STI571 ProspectIve RandomIzed Trial: SPIRIT

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 treatment) in patients with previously untreated CML in chronic phase.

To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Collaborators: Ministry of Health, France; Novartis; Roche Pharma AG
• Treatments: Cytarabine; Imatinib Mesylate; Interferons; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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