Status:
TERMINATED
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Ministry of Health, France
Novartis
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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: 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00219765
Start Date
May 1 2001
End Date
January 1 2006
Last Update
November 28 2005
Active Locations (1)
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1
University Hospital
Poitiers, France, 86021