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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126321
Recruitment Status : Unknown
Verified February 2010 by University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : August 3, 2005
Last Update Posted : February 2, 2010
Information provided by:
University Hospital, Bonn

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Drug: cladribine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
Study Start Date : November 2004
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : March 2011

Intervention Details:
  • Drug: cladribine
    2-chlorodeoxyadenosine, 2-CdA

Primary Outcome Measures :
  1. Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate [ Time Frame: continuous ]
  2. Rate of complete remission

Secondary Outcome Measures :
  1. Remission duration
  2. Overall survival
  3. Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival
  4. Course of CD3/CD4+ subpopulation after therapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126321

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Contact: Axel Glasmacher, MD +49-228-287-15507

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Medical Clinic & Policlinic III, University Bonn Recruiting
Bonn, Germany, 53105
Contact: Marie von Lilienfeld-Toal, MD    +49-228-287-22263   
Principal Investigator: Marie von Lilienfeld-Toal, MD         
Sponsors and Collaborators
University Hospital, Bonn
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Principal Investigator: Marie von Lilienfeld-Toal, MD Medical Clinic & Policlinic III, University Hospital Bonn
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Responsible Party: PD Dr. Marie von Lilienfeld-Toal, University Hospital, Med. Klinik III, Bonn, Germany Identifier: NCT00126321    
Other Study ID Numbers: CAI
First Posted: August 3, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: February 2010
Keywords provided by University Hospital, Bonn:
AML, relapsed
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs