Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Results in CP are better in patients treated early after the onset of the disease with respect to late CP . To date, the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk (88 and 84% versus 65%). High dose of imatinib, as shown in phase I-III trials may offer the possibility to increase the response rate of patients belonging to this risk category.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Age >/=18 years

• First chronic phase, less than 6 months of duration

• Intermediate Sokal's risk

• Ph positive

• No previous treatment or hydroxiurea only.

• Performance status (ECOG/WHO) < or = 2

• Written informed consent

Exclusion Criteria:

• Age <18

• Low or high Sokal risk score.

• More than 6 months from diagnosis.

• Second chronic, accelerated or blastic phase

• Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.

• Performance status (ECOG/WHO) > 2 (see Appendix 2)

• Inability to provide written informed consent

• Pregnancy

• Formal refusal of any recommendation of a safe contraception

• Alcohol or drug addiction

• Altered hepatic or renal function as defined by AST/ALT or bilirubine > 3 times upper normal limits (UNL) and by creatinine ³ 20mg/L Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.