Leukemia, Promyelocytic, AcutePhase 4NCT00180128
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
A Phase 4 study testing all-trans retinoid acid, idarubicin and mitoxantrone in people with Leukemia, Promyelocytic, Acute, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia, Promyelocytic, Acute
- What is being tested?
- all-trans retinoid acid, idarubicin and mitoxantrone
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2000to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
- no contraindication for chemotherapy
- written informed consent
Who cannot join
- severe comorbidities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine I, University Hospital Carl Gustav Carus
Dresden, 01307
Markus Schaich, MD, +49-351-458 ext. -4251, markus.schaich@uniklinikum-dresden.de
Silke Soucek, +49-351-458 ext. -4251, silke.soucek@uniklinikum-dresden.de
About this study
Official title: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
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.
Read the 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.
- Conditions
- Leukemia, Promyelocytic, Acute
- Being tested
- all-trans retinoid acid, idarubicin, mitoxantrone, daunorubicin, cytarabine
- Keywords
- acute promyelocytic leukemia, risk adapted therapy
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all-trans retinoid acidDrug
idarubicinDrug
mitoxantroneDrug
daunorubicinDrug
cytarabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Promyelocytic, AcuteStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Ehninger, MD, Principal investigator, Department of Medicine I, University Hospital Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180128
- Sponsor's protocol ID
- MK1-192
- Status last verified
- Jul 2011
- First submitted
- 12 Sep 2005
- Last updated
- 11 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)
- ClinicalTrials.gov ID
- NCT00180128
- Acronym / sponsor ID
- MK1-192
- Conditions
- Leukemia, Promyelocytic, Acute
- Keywords
- acute promyelocytic leukemia, risk adapted therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
- no contraindication for chemotherapy
- written informed consent
Key exclusion criteria (1 listed)
- severe comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all-trans retinoid acid | Drug | – |
| idarubicin | Drug | – |
| mitoxantrone | Drug | – |
| daunorubicin | Drug | – |
| cytarabine | Drug | – |
Primary outcome
overall survival
5 secondary outcomes
toxicity of the regimen
evaluation of additional risk factors
effectiveness of MRD as guidance for therapy decisions
relapse free survival
complete remission rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Ehninger, MD principal investigator
Department of Medicine I, University Hospital Carl Gustav Carus Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing all-trans retinoid acid, idarubicin and mitoxantrone in people with Leukemia, Promyelocytic, Acute, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Schaich, MD (+49-351-458 ext. -4251, markus.schaich@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.