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

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Status: Enrolling

Conditions: Relapsed APL; Newly-diagnosed APL (de Novo or Therapy-related)

Treatments: Other: observational

Study type: Observational

Funder types: Other

Identifiers

NCT02192619

NAPOLEON-Registry

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

observational

Treatment:

Other: observational