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

February 1, 2010 updated by: University Hospital, Bonn

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Recruiting
        • Medical Clinic & Policlinic III, University Bonn
        • Contact:
        • Principal Investigator:
          • Marie von Lilienfeld-Toal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
Time Frame: continuous
continuous
Rate of complete remission

Secondary Outcome Measures

Outcome Measure
Overall survival
Remission duration
Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival
Course of CD3/CD4+ subpopulation after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Marie von Lilienfeld-Toal, MD, Medical Clinic & Policlinic III, University Hospital Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 3, 2005

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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