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

NCT ID: NCT00180128

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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

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Leukemia, Promyelocytic, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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all-trans retinoid acid

Intervention Type DRUG

idarubicin

Intervention Type DRUG

mitoxantrone

Intervention Type DRUG

daunorubicin

Intervention Type DRUG

cytarabine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Dresden University of Technology

Principal Investigators

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Gerhard Ehninger, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine I, University Hospital Carl Gustav Carus Dresden

Locations

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Department of Medicine I, University Hospital Carl Gustav Carus

Dresden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus Schaich, MD

Role: CONTACT

+49-351-458 ext. -4251

Silke Soucek

Role: CONTACT

+49-351-458 ext. -4251

Facility Contacts

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Markus Schaich, MD

Role: primary

+49-351-458 ext. -4251

Silke Soucek

Role: backup

+49-351-458 ext. -4251

Other Identifiers

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MK1-192

Identifier Type: -

Identifier Source: org_study_id

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