NCT02192619

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
OTHER	observational

Timeline

• Start date: 2014-07-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2014-07-17
• Last updated: 2024-02-23

Locations

1 site across 1 country: Germany