- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180128
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
July 8, 2011 updated by: Technische Universität Dresden
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
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 Overview
Status
Unknown
Conditions
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 Contact
- Name: Markus Schaich, MD
- Phone Number: -4251 +49-351-458
- Email: markus.schaich@uniklinikum-dresden.de
Study Contact Backup
- Name: Silke Soucek
- Phone Number: -4251 +49-351-458
- Email: silke.soucek@uniklinikum-dresden.de
Study Locations
-
-
-
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
14 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
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
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
July 11, 2011
Last Update Submitted That Met QC Criteria
July 8, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia
- Leukemia, Promyelocytic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
- Idarubicin
- Mitoxantrone
Other Study ID Numbers
- MK1-192
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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