Registry for patients with acute promyelocytic leukemia
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
This study collects information from patients with acute promyelocytic leukemia to see how well treatments work and how they affect quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH Academic / other |
| Locations | 1 site (Dresden) |
| Trial ID | NCT02192619 on ClinicalTrials.gov |
What this trial studies
This observational registry collects epidemiological data, treatment outcomes, and quality of life information from patients diagnosed with acute promyelocytic leukemia (APL). It includes newly-diagnosed and relapsed APL patients, documenting their treatment efficacy and safety, as well as minimal residual disease status. The study also aims to validate prognostic factors and involves biobanking samples for future translational research. The approach is non-interventional and multicenter, focusing on real-world data collection.
Who should consider this trial
Good fit: Ideal candidates are patients who have been newly diagnosed with APL or have experienced a relapse within the last 12 months.
Not a fit: Patients who do not have APL or are diagnosed outside the specified time frame may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of APL and improve treatment strategies, ultimately leading to better patient outcomes.
How similar studies have performed: Other observational studies in hematology have shown success in improving treatment protocols and patient outcomes, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden
- Prof. Dr. U. Platzbecker — Dresden, Germany (Recruiting)
Study contacts
- Principal investigator: Richard F. Schlenk, Prof. Dr. — Universitätsklinikum Ulm, for the AML-SG group
- Study coordinator: Uwe Platzbecker, Prof. Dr.
- Email: Uwe.Platzbecker@medizin.uni-leipzig.de
- Phone: +49 351 458 3192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.