Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Conditions
Keywords
BPDCN, Tagraxofusp, ELZONRIS, Registry Study, Post Authorization, Chemotherapy
Brief summary
The main goal of this registry study is to investigate the effectiveness and safety of tagraxofusp in the treatment of adult participants with BPDCN in the real-world clinical practice setting.
Interventions
DRUGTagraxofusp
No study medication will be provided by the sponsor during this study.
Sponsors
Stemline Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosed with BPDCN, confirmed by hematopathology and biomarkers (inclusive of CD123, CD4, and CD56). * Planning to start treatment with tagraxofusp monotherapy for BPDCN at the time of, or within 6 months prior to, informed consent form (ICF) signature or has started treatment. Key
Exclusion criteria
* Currently (or planning to) participating in another study or registry where BPDCN treatment outcomes are reported. * Participating in an interventional clinical trial at the time of ICF signature. * Known allergic reactions to components of tagraxofusp. Note: Other protocol-specified criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment | Up to Month 4 |
| Number of Participants Experiencing Capillary Leak Syndrome | Up to Month 51 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Receive Stem Cell Transplant (SCT) | Up to Month 66 |
| Progression-free Survival (PFS) | Up to Month 66 |
| Overall Survival (OS) | Up to Month 66 |
| Best Overall Response (BOR) | Up to Month 66 |
| Duration of Response (DOR) | Up to Month 66 |
| Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation | Up to Month 66 |
| Number of Participants with Adverse Events of Special Interest (AESI) | Up to Month 66 |
| Number of Participants with Adverse Events (AEs) | Up to Month 66 |
| Number of Doses/Cycles of Tagraxofusp Administered | Up to Month 66 |
Countries
Austria, Germany, Italy, Switzerland
Contacts
CONTACTStemline Trials
STUDY_DIRECTORMedical Director
Stemline Therapeutics, Inc.
Outcome results
None listed