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

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00180128
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 154
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Promyelocytic, Acute	Drug: all-trans retinoid acid; Drug: idarubicin; Drug: mitoxantrone; Drug: daunorubicin; Drug: cytarabine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
• Study Start Date: Jan 1, 2000
• Anticipated Primary Completion Date: Nov 1, 2012
• Anticipated Study Completion Date: Nov 1, 2012

Outcome Measures

Primary Outcome Measures

1. overall survival []

Secondary Outcome Measures

1. toxicity of the regimen []

2. evaluation of additional risk factors []

3. effectiveness of MRD as guidance for therapy decisions []

4. relapse free survival []

5. complete remission rate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine I, University Hospital Carl Gustav Carus	Dresden		Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Principal Investigator: Gerhard Ehninger, MD, Department of Medicine I, University Hospital Carl Gustav Carus Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00180128
• Other Study ID Numbers: MK1-192
• First Posted: Sep 16, 2005
• Last Update Posted: Jul 11, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: acute promyelocytic leukemia; risk adapted therapy
• Additional relevant MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute; Cytarabine; Daunorubicin; Mitoxantrone; Idarubicin

Study Results

No Results Posted as of Jul 11, 2011