Clinical trial · Observational
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
NCT02192619CI-TRIAL-00074310unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly-diagnosed APL (de Novo or Therapy-related) | — | UNRESOLVED | — |
| Relapsed APL | Acute Promyelocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- observational
- interventionNames
- Other: observational
Primary outcomes (4)
- measure
- epidemiological parameters
- timeFrame
- yearly follow up for 5 years
- measure
- diagnostic quality indicators
- timeFrame
- yearly follow up for 5 years
- measure
- type of therapy
- timeFrame
- yearly follow up for 5 years
- measure
- response, recurrence and time of death and resulting outcomes RFS and OS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKayser 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. PMID 34047178