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NCT00180128 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE4
Status at capture
UNKNOWN
Registry last update
2011-07-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    all-trans retinoid acid
    type
    DRUG
  2. name
    idarubicin
    type
    DRUG
  3. name
    mitoxantrone
    type
    DRUG
  4. name
    daunorubicin
    type
    DRUG
  5. name
    cytarabine
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
PREVENTION
Enrollment
count
80
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    overall survival
secondary Outcomes
  1. measure
    toxicity of the regimen
  2. measure
    evaluation of additional risk factors
  3. measure
    effectiveness of MRD as guidance for therapy decisions
  4. measure
    relapse free survival
  5. measure
    complete remission rate
Full 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.
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.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        y, followed by ATO-based consolidation therapy for high-risk disease):</p> <div class="pdq-content-list"><ol id="_685"><li>The <a href="/clinicaltrials/NCT00180128">AIDA-2000</a> study (NCT00180128) combined oral ATRA until CR or for a maximum of 45 days and four doses of intravenous idarubicin (12 mg/m<span class="sup">
        end
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        exact text
        NCT00180128
        start
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      2. context exact
        tion therapy for high-risk disease):</p> <div class="pdq-content-list"><ol id="_685"><li>The <a href="/clinicaltrials/NCT00180128">AIDA-2000</a> study (NCT00180128) combined oral ATRA until CR or for a maximum of 45 days and four doses of intravenous idarubicin (12 mg/m<span class="sup">2</span>) on days 2, 4, 6, and 8.
        end
        277623
        exact text
        NCT00180128
        start
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      source file
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      source retrieved at
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      source string sha256
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      source title
      Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 14, 2025
        datetime
        2025-03-14T12:00:00Z
        display
        March 14, 2025

    Preserved source evidence · Not medical advice