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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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* 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

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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observational

Intervention Type OTHER

Interventions

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observational

Intervention Type OTHER

Eligibility Criteria

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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