We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00180128
Recruitment Status : Unknown
Verified July 2011 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Technische Universität Dresden

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia, Promyelocytic, Acute Drug: all-trans retinoid acid Drug: idarubicin Drug: mitoxantrone Drug: daunorubicin Drug: cytarabine Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
Study Start Date : January 2000
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. toxicity of the regimen
  2. evaluation of additional risk factors
  3. effectiveness of MRD as guidance for therapy decisions
  4. relapse free survival
  5. complete remission rate

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00180128


Contacts
Layout table for location contacts
Contact: Markus Schaich, MD +49-351-458 ext -4251 markus.schaich@uniklinikum-dresden.de
Contact: Silke Soucek +49-351-458 ext -4251 silke.soucek@uniklinikum-dresden.de

Locations
Layout table for location information
Germany
Department of Medicine I, University Hospital Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Markus Schaich, MD    +49-351-458 ext -4251    markus.schaich@uniklinikum-dresden.de   
Contact: Silke Soucek    +49-351-458 ext -4251    silke.soucek@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Layout table for investigator information
Principal Investigator: Gerhard Ehninger, MD Department of Medicine I, University Hospital Carl Gustav Carus Dresden
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Prof. Dr. Gerhard Ehninger, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00180128    
Other Study ID Numbers: MK1-192
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: July 2011
Keywords provided by Technische Universität Dresden:
acute promyelocytic leukemia
risk adapted therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cytarabine
Daunorubicin
Mitoxantrone
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents