Idarubicin and Mitoxantrone and cytarabine in Leukemia, Promyelocytic, Acute - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Leukemia, Promyelocytic, Acute

Intervention / Treatment

Detailed Description

In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

Phase 4

Contacts and Locations

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

Study Locations

Germany
- - Dresden, Germany, 01307
    - Recruiting
    - Department of Medicine I, University Hospital Carl Gustav Carus
    - Contact:
      
      Markus Schaich, MD
      
      Phone Number: -4251 +49-351-458
      
      Email: markus.schaich@uniklinikum-dresden.de
    - Contact:
      
      Silke Soucek
      
      Phone Number: -4251 +49-351-458
      
      Email: silke.soucek@uniklinikum-dresden.de

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
no contraindication for chemotherapy
written informed consent

Exclusion Criteria:

- severe comorbidities

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: Prevention
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
overall survival

Secondary Outcome Measures

Outcome Measure
toxicity of the regimen
evaluation of additional risk factors
effectiveness of MRD as guidance for therapy decisions
relapse free survival
complete remission rate

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

Principal Investigator: Gerhard Ehninger, MD, Department of Medicine I, University Hospital Carl Gustav Carus Dresden

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

January 1, 2000

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria