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

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.

Study Overview

• Status: Recruiting
• Conditions: Newly-diagnosed APL (de Novo or Therapy-related); Relapsed APL
• Intervention / Treatment: Other: observational

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Uwe Platzbecker, Prof. Dr.; Phone Number: +49 351 458 3192; Email: Uwe.Platzbecker@medizin.uni-leipzig.de
• Study Contact Backup: Name: Michaela Weier; Phone Number: +49 351 458 3192; Email: michaela.weier@ukdd.de

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • Prof. Dr. U. Platzbecker
    • Contact: Uwe Platzbecker, Prof. Dr.; Phone Number: +49 351 458 3192; Email: Uwe.Platzbecker@medizin.uni-leipzig.de
    • Contact: Michaela Weier; Phone Number: +49 351 458 3192; Email: michaela.weier@ukdd.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a therapeutic intervention according to their disease state are the study population within this registry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observational	Other: observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
• Investigators: Principal Investigator: Richard F. Schlenk, Prof. Dr., Universitätsklinikum Ulm, for the AML-SG group; Principal Investigator: Eva Lengfelder, PD Dr., Universitätsklinikum Mannheim; Principal Investigator: Dietger Niederwieser, Prof. Dr., Universitatsklinikum Leipzig

Publications and helpful links

General Publications

• Kayser S, Schlenk RF, Lebon D, Carre M, Gotze KS, Stolzel F, Berceanu A, Schafer-Eckart K, Peterlin P, Hicheri Y, Rahme R, Raffoux E, Chermat F, Krause SW, Aulitzky WE, Rigaudeau S, Noppeney R, Berthon C, Gorner M, Jost E, Carassou P, Keller U, Orvain C, Braun T, Saillard C, Arar A, Kunzmann V, Wemeau M, De Wit M, Niemann D, Bonmati C, Schwanen C, Abraham J, Aljijakli A, Haiat S, Kramer A, Reichle A, Gnadler M, Willekens C, Spiekermann K, Hiddemann W, Muller-Tidow C, Thiede C, Rollig C, Serve H, Bornhauser M, Baldus CD, Lengfelder E, Fenaux P, Platzbecker U, Ades L. Characteristics and outcome of patients with low-/intermediate-risk acute promyelocytic leukemia treated with arsenic trioxide: an international collaborative study. Haematologica. 2021 Dec 1;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimated): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: APL; acute promyelocytic leukemia; AML M3
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia; Leukemia, Promyelocytic, Acute
• Other Study ID Numbers: NAPOLEON-Registry