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

Leukemia, Promyelocytic, Acute Clinical Trial

Official title:

AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180128
• Other study ID #: MK1-192
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 8, 2011
• Start date: January 2000
• Est. completion date: November 2012

Study information

• Verified date: July 2011
• Source: Technische Universität Dresden
• Contact: Markus Schaich, MD
• Phone: +49-351-458
• Email: markus.schaich[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• all-trans retinoid acid

• idarubicin

• mitoxantrone

• daunorubicin

• cytarabine

Locations

Country	Name	City	State
Germany	Department of Medicine I, University Hospital Carl Gustav Carus	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	toxicity of the regimen
Secondary	evaluation of additional risk factors
Secondary	effectiveness of MRD as guidance for therapy decisions
Secondary	relapse free survival
Secondary	complete remission rate