Newly-diagnosed APL (de Novo or Therapy-related), Relapsed APL
Conditions
Keywords
APL, acute promyelocytic leukemia, AML M3
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
Interventions
OTHERobservational
Sponsors
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| epidemiological parameters | yearly follow up for 5 years |
| diagnostic quality indicators | yearly follow up for 5 years |
Secondary
| Measure | Time frame |
|---|---|
| complete remission (CR) and CRm | yearly follow up for 5 years |
| quality of life (QoL): EORTC QLQ-C30 | 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 |
Countries
Germany
Contacts
Primary ContactUwe Platzbecker, Prof. Dr.
Backup ContactMichaela Weier
Outcome results
None listed