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National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup

National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

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

Study details
    Newly-diagnosed APL (de Novo or Therapy-related)
    Relapsed APL

NCT02192619

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

14 October 2025

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