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Trial Title:
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
NCT ID:
NCT02192619
Condition:
Newly-diagnosed APL (de Novo or Therapy-related)
Relapsed APL
Conditions: Official terms:
Leukemia
Leukemia, Promyelocytic, Acute
Conditions: Keywords:
APL
acute promyelocytic leukemia
AML M3
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
observational
Arm group label:
observational
Summary:
The registry aims to document epidemiologic data, treatment and long-term outcome as well
as quality of life of patients with APL. Additionally, a biobanking project for further
translational studies is integrated.
Prospective population-based non-interventional and non-randomized multicenter registry.
Detailed description:
- collection of epidemiological data for APL: age distribution, prognostic factors,
distribution of subgroups, incidence
- documentation of efficacy and safety of the first line and salvage therapy in APL
including
- documentation of minimal residual disease (MRD)
- correlation of clinical outcomes with chosen therapy
- collection and evaluation of quality of life
- validation of published prognostic factors / new potential prognostic factors
- acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking
and translational studies under the umbrella of the specific study-group biobanking
concepts
Criteria for eligibility:
Study pop:
Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a
therapeutic intervention according to their disease state are the study population within
this registry.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- newly-diagnosed APL (either de novo or therapy-related), within 12 months of
diagnosis
- or relapsed APL, within 12 months of diagnosis of relapse
1. confirmed by the presence of the translocation t(15; 17)
2. and / or confirmed by the detection of the fusion transcript of PML/RARa
Exclusion Criteria:
- none
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Prof. Dr. U. Platzbecker
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Uwe Platzbecker, Prof. Dr.
Phone:
+49 351 458 3192
Email:
Uwe.Platzbecker@medizin.uni-leipzig.de
Contact backup:
Last name:
Michaela Weier
Phone:
+49 351 458 3192
Email:
michaela.weier@ukdd.de
Start date:
July 2014
Completion date:
December 2024
Lead sponsor:
Agency:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Agency class:
Other
Source:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02192619
http://www.gmiho.de/
http://www.aml-germany.com/
