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STI571 ProspectIve RandomIzed Trial: SPIRIT

NCT00219739

CompletedPhase 3

Sponsor: Poitiers University Hospital

Conditions: Chronic Myeloid Leukemia

Interventions: Imatinib mesylate 400 mg, Imatinib mesylate 600 mg, Imatinib 400 mg + Peg-Interferon, Imatinib mesylate 400 mg + Cytarabine

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Poitiers, France