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

Poitiers University Hospital

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Imatinib mesylate 600 mg

Drug: Cytarabine

Drug: Daunorubicine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00219765

CSTI571AFR01

010495

Details and patient eligibility

About

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.

Full description

Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels

level 1: 0

level 2: 15mg/m² ; 3 days

level 3: 30mg/m² ; 3 days

level 4: 45mg/m² ; 3 days

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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