Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients

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

Summary

The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Collaborators: Ministry of Health, France; Novartis
• Treatments: Cytarabine; Daunorubicin; Imatinib Mesylate

Criteria

Inclusion Criteria:

• CML Ph+ (assessed by cytogenetic or FISH)

• Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)

• Age ≥ 18 year at inclusion

• PS grade 0 to 2 (ECOG)

• Adequate and organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.

• Informed consent signed up

Exclusion Criteria:

• active malignancy other than CML or non-melanoma cancer of the skin

• current treatment with another investigational agent

• patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.

• patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.

• patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4