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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00126321
First received: August 2, 2005
Last updated: February 1, 2010
Last verified: February 2010

August 2, 2005
February 1, 2010
November 2004
November 2010   (final data collection date for primary outcome measure)
  • Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Rate of complete remission [ Designated as safety issue: No ]
  • Toxicity according to NCI/CTC, especially the rate of severe infections and the death rate
  • Rate of complete remission
Complete list of historical versions of study NCT00126321 on ClinicalTrials.gov Archive Site
  • Remission duration [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival [ Designated as safety issue: No ]
  • Course of CD3/CD4+ subpopulation after therapy [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)
Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myelocytic, Acute
Drug: cladribine
2-chlorodeoxyadenosine, 2-CdA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Axel Glasmacher, MD +49-228-287-15507 glasmacher@uni-bonn.de
Germany
 
NCT00126321
CAI
No
PD Dr. Marie von Lilienfeld-Toal, University Hospital, Med. Klinik III, Bonn, Germany
University Hospital, Bonn
Not Provided
Principal Investigator: Marie von Lilienfeld-Toal, MD Medical Clinic & Policlinic III, University Hospital Bonn
University Hospital, Bonn
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP