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

Tracking Information
First Submitted Date ICMJE	August 2, 2005
First Posted Date ICMJE	August 3, 2005
Last Update Posted Date	February 2, 2010
Study Start Date ICMJE	November 2004
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 1, 2010)	Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate [ Time Frame: continuous ]; Rate of complete remission
Original Primary Outcome Measures ICMJE; (submitted: August 2, 2005)	Toxicity according to NCI/CTC, especially the rate of severe infections and the death rate; Rate of complete remission
Change History	Complete list of historical versions of study NCT00126321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 11, 2006)	Remission duration; Overall survival; Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival; Course of CD3/CD4+ subpopulation after therapy
Original Secondary Outcome Measures ICMJE; (submitted: August 2, 2005)	Remission duration; Overall survival; Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival; Course of CD3/CD4+ subpopulation after therapy; Sub-group analysis in patients with less intensive therapy
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)
Official Title ICMJE	Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
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.
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia, Myelocytic, Acute
Intervention ICMJE	Drug: cladribine; 2-chlorodeoxyadenosine, 2-CdA
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 2, 2005)	50
Original Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2011
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00126321
Other Study ID Numbers ICMJE	CAI
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	PD Dr. Marie von Lilienfeld-Toal, University Hospital, Med. Klinik III, Bonn, Germany
Study Sponsor ICMJE	University Hospital, Bonn
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Marie von Lilienfeld-Toal, MD Medical Clinic & Policlinic III, University Hospital Bonn
PRS Account	University Hospital, Bonn
Verification Date	February 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP