A Registry-study of ELZONRIS in Participants With BPDCN

Stemline Therapeutics, Inc.80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

TagraxofuspDRUG

No study medication will be provided by the sponsor during this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (41)

Outcomes

Primary Outcomes

Number of Participants Achieving Complete Response After 3 Months (+/- 1 month) of Treatment

Time frame: Up to Month 4

Number of Participants Experiencing Capillary Leak Syndrome

Time frame: Up to Month 51

Secondary Outcomes

Number of Participants Who Receive Stem Cell Transplant (SCT)

Time frame: Up to Month 66

Progression-free Survival (PFS)

Time frame: Up to Month 66

Overall Survival (OS)

Time frame: Up to Month 66

Best Overall Response (BOR)

Time frame: Up to Month 66

Duration of Response (DOR)

Time frame: Up to Month 66

Number of Participants with Dose Interruptions and/or Requiring Administration of Intravenous Albumin Supplementation

Time frame: Up to Month 66

Number of Participants with Adverse Events of Special Interest (AESI)

Time frame: Up to Month 66

Number of Participants with Adverse Events (AEs)

Time frame: Up to Month 66

Number of Doses/Cycles of Tagraxofusp Administered

Time frame: Up to Month 66

Central Contacts

Stemline Trials

CONTACT

1-877-332-7967 clinicaltrials@menarinistemline.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Ordensklinikum Linz Krankenhaus der Elisabethinen Linz

Linz, Austria

RECRUITING

Salzburg Cancer Research Institute (SCRI)

Salzburg, Austria

RECRUITING

Medizinische Universitat Wien, Department for Internal Medicine I, Division of Hematology and Haemostaseology

Vienna, Austria

RECRUITING

Universitätsklinikum Augsburg

Augsburg, Germany

RECRUITING

Hospital Bielefeld

Bielefeld, Germany

RECRUITING

Klinikum Chemnitz

Chemnitz, Germany

RECRUITING

University Clinic of Frankfurt

Frankfurt, Germany

RECRUITING

University clinic of Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Universitätsmedizin Halle

Halle, Germany

RECRUITING

...and 31 more locations