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

NCT00126321 | Unknown Phase 2

• 1 other identifier: CAI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myelocytic, Acute

Keywords

AML, relapsed; cladribine; chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Remission duration

• Overall survival

• Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival

• Course of CD3/CD4+ subpopulation after therapy

Interventions

cladribine DRUG

2-chlorodeoxyadenosine, 2-CdA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior therapy of AML with cladribine
• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Medical Clinic & Policlinic III, University Bonn

Bonn, 53105, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Marie von Lilienfeld-Toal, MD

  Medical Clinic & Policlinic III, University Hospital Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Glasmacher, MD

CONTACT

+49-228-287-15507; glasmacher@uni-bonn.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2005
• First Posted: August 3, 2005
• Study Start: November 1, 2004
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 2, 2010

Record last verified: 2010-02

Locations

DE (1)