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Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia

Phase 2
18 Years
Open (Enrolling)
Leukemia, Myelocytic, Acute

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Trial Information

Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia

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.

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

- Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Marie von Lilienfeld-Toal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Clinic & Policlinic III, University Hospital Bonn


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2004

Completion Date:

March 2011

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • AML, relapsed
  • cladribine
  • chemotherapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid