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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

16 and over

Other

MK1-192
NCT00180128

Trial Description

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.

Further Study Information

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Technische Universitaet Dresden

Gerhard Ehninger, MD

Principal Investigator

Markus Schaich, MD		Ph: +49-351-458 Ext.-4251
		Email: markus.schaich@uniklinikum-dresden.de

Silke Soucek		Ph: +49-351-458 Ext.-4251
		Email: silke.soucek@uniklinikum-dresden.de

Trial Sites

Germany

Dresden

Universitatsklinikum Carl Gustav Carus

Markus Schaich, MD Ph: +49-351-458 Ext.-4251

Email: markus.schaich@uniklinikum-dresden.de

Silke Soucek Ph: +49-351-458 Ext.-4251

Email: silke.soucek@uniklinikum-dresden.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00180128
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.