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| Sponsored by: |
Dresden University of Technology |
|---|---|
| Information provided by: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00180128 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL) |
| 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) |
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
- severe comorbidities
Contacts and Locations| 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 |
| 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 | |
| Principal Investigator: | Gerhard Ehninger, MD | Department of Medicine I, University Hospital Carl Gustav Carus Dresden |
More Information
| Responsible Party: | Dresden University of Technology ( Prof. Dr. Gerhard Ehninger ) |
| Study ID Numbers: | MK1-192 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00180128 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
acute promyelocytic leukemia risk adapted therapy |
|
Daunorubicin Leukemia Idarubicin Acute promyelocytic leukemia Leukemia, Promyelocytic, Acute |
Mitoxantrone Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |
