A Registry-study of ELZONRIS in Participants With BPDCN
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStemline Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult participants with BPDCN who are to be treated (or have recently started treatment) with tagraxofusp as first-line therapy according to the European Union summary of product characteristics in standard clinical practice setting across Europe. Participants who are relapse/refractory to prior treatment will also be investigated.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tagraxofusp
DrugNo study medication will be provided by the sponsor during this study.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Primary Cohort: Previously Untreated1 intervention
Group B: Exploratory Cohort: Relapsed/Refractory1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment
Time frame
Up to Month 42
Number of Participants Experiencing Capillary Leak Syndrome
Time frame
Up to Month 51Secondary outcomes
1
Number of Participants Who Receive Stem Cell Transplant (SCT)
Time frame
Up to Month 662
Progression-free Survival (PFS)
Time frame
Up to Month 663
Overall Survival (OS)
Time frame
Up to Month 664
Best Overall Response (BOR)
Time frame
Up to Month 66Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov