Brief Title
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Official Title
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Brief 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
Study Type
Observational [Patient Registry]
Primary Outcome
epidemiological parameters
Secondary Outcome
complete remission (CR) and CRm
Condition
Newly-diagnosed APL (de Novo or Therapy-related)
Intervention
observational
Study Arms / Comparison Groups
observational
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
500
Start Date
July 2014
Completion Date
December 2023
Primary Completion Date
December 2023
Eligibility 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
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Richard F. Schlenk, Prof. Dr., +49 351 458 3192, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02192619
Organization ID
NAPOLEON-Registry
Responsible Party
Sponsor
Study Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study Sponsor
Richard F. Schlenk, Prof. Dr., Principal Investigator, Universitätsklinikum Ulm, for the AML-SG group
Verification Date
March 2022