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

Sponsor

University Hospital, Bonn (Other)

Overall Status

Unknown status

CT.gov ID

NCT00126321

Collaborator

(none)

Enrollment

Location

75.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myelocytic, Acute	Drug: cladribine	Phase 2

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2004

Anticipated Primary Completion Date :

Nov 1, 2010

Anticipated Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate [continuous]
Rate of complete remission []

Secondary Outcome Measures

Remission duration []
Overall survival []
Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival []
Course of CD3/CD4+ subpopulation after therapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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