Overview

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