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.

Condition	Intervention	Phase
Leukemia, Myelocytic, Acute	Drug: cladribine	Phase II

Further Study Details: 

Primary Outcomes: Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate; Rate of complete remission
Secondary Outcomes: Remission duration; Overall survival; Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival; Course of CD3/CD4+ subpopulation after therapy; Sub-group analysis in patients with less intensive therapy
Expected Total Enrollment:  50

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 nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.

The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00126321

Axel Glasmacher, MD      +49-228-287-5507    glasmacher@uni-bonn.de

Germany
      Medical Clinic & Policlinic I, University Bonn, Bonn,  53105,  Germany; Recruiting

Study chairs or principal investigators

Axel Glasmacher, MD,  Principal Investigator,  Medical Clinic & Policlinic I, University Hospital Bonn   

Study ID Numbers:  CAI
Last Updated:  August 17, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126321
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-23