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
  Purpose

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 Intervention Phase
Leukemia, Myelocytic, Acute
Drug: cladribine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2004
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cladribine
    2-chlorodeoxyadenosine, 2-CdA
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126321

Contacts
Contact: Axel Glasmacher, MD +49-228-287-15507 glasmacher@uni-bonn.de

Locations
Germany
Medical Clinic & Policlinic III, University Bonn Recruiting
Bonn, Germany, 53105
Contact: Marie von Lilienfeld-Toal, MD    +49-228-287-22263    m.lilienfeld.toal@uni-bonn.de   
Principal Investigator: Marie von Lilienfeld-Toal, MD         
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Marie von Lilienfeld-Toal, MD Medical Clinic & Policlinic III, University Hospital Bonn
  More Information

No publications provided

Responsible Party: PD Dr. Marie von Lilienfeld-Toal, University Hospital, Med. Klinik III, Bonn, Germany
ClinicalTrials.gov Identifier: NCT00126321     History of Changes
Other Study ID Numbers: CAI
Study First Received: August 2, 2005
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
AML, relapsed
cladribine
chemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cladribine
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014