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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Technische Universität Dresden.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180128
First Posted: September 16, 2005
Last Update Posted: July 11, 2011
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.
Information provided by:
Technische Universität Dresden
  Purpose
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 Intervention Phase
Leukemia, Promyelocytic, Acute Drug: all-trans retinoid acid Drug: idarubicin Drug: mitoxantrone Drug: daunorubicin Drug: cytarabine Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • overall survival

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

Estimated Enrollment: 80
Study Start Date: January 2000
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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
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
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
Principal Investigator: Gerhard Ehninger, MD Department of Medicine I, University Hospital Carl Gustav Carus Dresden
  More Information

Responsible Party: Prof. Dr. Gerhard Ehninger, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00180128     History of Changes
Other Study ID Numbers: MK1-192
First Submitted: September 12, 2005
First Posted: September 16, 2005
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:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cytarabine
Mitoxantrone
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic