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

Recruiting

• Conditions: Newly-diagnosed APL (de Novo or Therapy-related); Relapsed APL
• Interventions: Other: observational

• Registration Number: NCT02192619
• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Brief 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational	observational	-

Primary Outcome Measures

Name	Time	Method
epidemiological parameters	yearly follow up for 5 years
diagnostic quality indicators	yearly follow up for 5 years
response, recurrence and time of death and resulting outcomes RFS and OS	yearly follow up for 5 years
type of therapy	yearly follow up for 5 years

Secondary Outcome Measures

Name	Time	Method
grade IV toxicities	yearly follow up for 5 years
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
quality of life (QoL): EORTC QLQ-C30	yearly follow up for 5 years

Trial Locations

Locations (1)

Prof. Dr. U. Platzbecker; 🇩🇪 Dresden, Germany