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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00126321
Other study ID # CAI
Secondary ID
Status Recruiting
Phase Phase 2
First received August 2, 2005
Last updated February 1, 2010
Start date November 2004
Est. completion date March 2011

Study information

Verified date February 2010
Source University Hospital, Bonn
Contact Axel Glasmacher, MD
Phone +49-228-287-15507
Email glasmacher@uni-bonn.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
cladribine
2-chlorodeoxyadenosine, 2-CdA

Locations

Country Name City State
Germany Medical Clinic & Policlinic III, University Bonn Bonn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate continuous Yes
Primary Rate of complete remission No
Secondary Remission duration No
Secondary Overall survival No
Secondary Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival No
Secondary Course of CD3/CD4+ subpopulation after therapy No
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