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National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Conditions
Newly-diagnosed APL (de Novo or Therapy-related) - Relapsed APL
Conditions: official terms
Leukemia, Promyelocytic, Acute
Conditions: Keywords
APL, acute promyelocytic leukemia, AML M3
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: observational
Type: Other
Overall Status
Recruiting
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.
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
- 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Prof. Dr. U. Platzbecker
Dresden, Germany
Status: Recruiting
Contact: Uwe Platzbecker, Prof. Dr. - +49 351 458 3192 - uwe.platzbecker@uniklinikum-dresden.de
Start Date
June 2014
Completion Date
December 2020
Sponsors
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Source
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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