Chronic Myeloid Leukemia
Conditions
Keywords
CML, Acute Phase, Imatinib mesylate, Cytarabine, Daunorubicine
Brief 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.
Detailed 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
Interventions
Sponsors
Ministry of Health, France
Novartis
Poitiers University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points. | — |
| - To evaluate duration of responses and failure to respond | — |
Countries
France
Outcome results
None listed