Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Treatments: Cladribine; Cytarabine; Idarubicin

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