Status:
UNKNOWN
Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)
Lead Sponsor:
University Hospital, Bonn
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.
Detailed Description
Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine n...
Eligibility Criteria
Inclusion
- Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR
- Age \>= 18 years
- Life expectancy of at least three months (without consideration of AML and complications)
- Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications)
- Written informed consent
Exclusion
- Prior therapy of AML with cladribine
- Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection)
- Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- Severe renal insufficiency with a clearance of \< 30 ml/min (if not due to AML)
- Severe hepatic insufficiency with bilirubin \> 3 mg/dl or AST \> 200 U/l (if not due to AML)
- Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study)
- HIV infection
- Intolerance to study drugs
- Pregnant or breast-feeding women
- Any other malignant disease which will probably affect the course of AML
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00126321
Start Date
November 1 2004
End Date
March 1 2011
Last Update
February 2 2010
Active Locations (1)
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1
Medical Clinic & Policlinic III, University Bonn
Bonn, Germany, 53105