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

NCT00180128 | Unknown Phase 4

• 1 other identifier: MK1-192
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Promyelocytic, Acute

Keywords

acute promyelocytic leukemia; risk adapted therapy

Outcome Measures

Primary Outcomes (1)

• overall survival

Secondary Outcomes (5)

• toxicity of the regimen

• evaluation of additional risk factors

• effectiveness of MRD as guidance for therapy decisions

• relapse free survival

• complete remission rate

Interventions

all-trans retinoid acid DRUG

idarubicin DRUG

mitoxantrone DRUG

daunorubicin DRUG

cytarabine DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
• no contraindication for chemotherapy
• written informed consent

You may not qualify if:

• \- severe comorbidities

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Medicine I, University Hospital Carl Gustav Carus

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Idarubicin; Mitoxantrone; Daunorubicin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Anthraquinones; Anthrones; Anthracenes; Quinones; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gerhard Ehninger, MD

  Department of Medicine I, University Hospital Carl Gustav Carus Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Schaich, MD

CONTACT

+49-351-458; markus.schaich@uniklinikum-dresden.de

Silke Soucek

CONTACT

+49-351-458; silke.soucek@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2000
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 11, 2011

Record last verified: 2011-07

Locations

DE (1)