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

Study Overview
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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.

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

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

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

Intervention / Treatment
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* Other: observational


Participation Criteria
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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 confirmed by the presence of the translocation t(15; 17) and / or confirmed by the detection of the fusion transcript of PML/RARa Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational<br> | Other: observational<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiological parameters |  | yearly follow up for 5 years | 
| diagnostic quality indicators |  | yearly follow up for 5 years | 
| type of therapy |  | yearly follow up for 5 years | 
| response, recurrence and time of death and resulting outcomes RFS and OS |  | yearly follow up for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission (CR) and CRm |  | yearly follow up for 5 years | 
| treatment related mortality (TRM) |  | yearly follow up for 5 years | 
| cumulative incidence of relapse (CIR) |  | yearly follow up for 5 years | 
| grade IV toxicities |  | yearly follow up for 5 years | 
| quality of life (QoL): EORTC QLQ-C30 |  | yearly follow up for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APL, acute promyelocytic leukemia, AML M3