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

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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

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 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
U.S. FDA Resources




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


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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


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

Responsible Party: Prof. Dr. Gerhard Ehninger, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00180128     History of Changes
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:
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