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Status unknownNCT00180128Updated Jul 11, 2011

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

A Phase 4 interventional study of all-trans retinoid acid and idarubicin in Leukemia, Promyelocytic, Acute, sponsored by Technische Universität Dresden. Status unknown at 1 site in Germany. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2011-07-11.

Sponsored by Technische Universität Dresden · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Leukemia, Promyelocytic, Acute

Keywords

  • acute promyelocytic leukemia
  • risk adapted therapy
03

In context

Leukemia, Promyelocytic, Acute

110 studies on the registry are indexed under Leukemia, Promyelocytic, Acute; 17 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 87 interventional studies indexed under Leukemia, Promyelocytic, Acute.

Browse Leukemia, Promyelocytic, Acute studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

- severe comorbidities

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. overall survival

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2000, a primary completion of Nov 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 16, 2005
Start
Jan 2000
Primary completionEst.
Nov 2012
CompletionEst.
Nov 2012
Last update
Jul 11, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00180128
Lead sponsor
Technische Universität Dresden
First posted
Sep 16, 2005
Start date
Jan 2000
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Jul 11, 2011

Study contacts

Markus Schaich, MD
Contact
markus.schaich@uniklinikum-dresden.de
+49-351-458 ext. -4251
Silke Soucek
Contact
silke.soucek@uniklinikum-dresden.de
+49-351-458 ext. -4251
Gerhard Ehninger, MD
principal investigator · Department of Medicine I, University Hospital Carl Gustav Carus Dresden
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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