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

Leukemia, Myelocytic, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00126321
• Other study ID #: CAI
• 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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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