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

Newly-diagnosed APL (de Novo or Therapy-related) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02192619
• Other study ID #: NAPOLEON-Registry
• Status: Recruiting
• Start date: July 2014
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
• Contact: Uwe Platzbecker, Prof. Dr.
• Phone: +49 351 458 3192
• Email: Uwe.Platzbecker[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute
• Newly-diagnosed APL (de Novo or Therapy-related)
• Relapsed APL

Intervention

Other:
• observational

Locations

Country	Name	City	State
Germany	Prof. Dr. U. Platzbecker	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidemiological parameters		yearly follow up for 5 years
Primary	diagnostic quality indicators		yearly follow up for 5 years
Primary	type of therapy		yearly follow up for 5 years
Primary	response, recurrence and time of death and resulting outcomes RFS and OS		yearly follow up for 5 years
Secondary	complete remission (CR) and CRm		yearly follow up for 5 years
Secondary	treatment related mortality (TRM)		yearly follow up for 5 years
Secondary	cumulative incidence of relapse (CIR)		yearly follow up for 5 years
Secondary	grade IV toxicities		yearly follow up for 5 years
Secondary	quality of life (QoL): EORTC QLQ-C30		yearly follow up for 5 years

External Links

•   Related Info
•   Related Info