RecruitingOBSERVATIONAL

A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy

This study is designed to understand how current chemotherapy treatments are used and how well they work for adults diagnosed with a rare type of blood cancer called Blastic Plasmacytoid Dendritic Cell Neoplasm, or BPDCN. It's not testing a new drug; instead, it's observing patients who have already received standard chemotherapy as their first treatment for BPDCN since May 2016. The main goals are to gather information on the safety and effectiveness of these treatments. This information will also help create a baseline for doctors to compare with results from trials of newer treatments for BPDCN, like the ELZONRIS drug.

At a glance

Status

Recruiting

Sponsor

Stemline Therapeutics, Inc.

Enrolment target

140

Start

17 Oct 2025

Estimated completion

01 Dec 2027

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

What is this study about?

This study is designed to help us understand more about a rare type of blood cancer called Blastic Plasmacytoid Dendritic Cell Neoplasm, often shortened to BPDCN. It's not a trial where you would be given a new, experimental drug. Instead, it's an 'observational' study. This means researchers are looking back at the medical records of people who have already been treated for BPDCN with standard chemotherapy in the UK.

The main purpose is to see how safe these chemotherapy treatments are and how well they have worked for patients. Because BPDCN is so rare, it can be hard to gather enough information. This study helps doctors learn from real-life treatment experiences.

Another important reason for this study is to create a clear picture of how BPDCN has been treated in the past. This will be very helpful for future studies. When new drugs for BPDCN are being tested, like the one called ELZONRIS, doctors can compare how well they work against the information collected in this study about traditional chemotherapy. This helps them understand if new treatments are better or safer.

Key takeaways

This study helps us understand a rare blood cancer called BPDCN.
It looks back at how chemotherapy treatments have worked for patients in the UK.
It's an 'observational' study, meaning no new treatments or hospital visits for you.
The information gathered will help improve future care and treatments for BPDCN.
Your medical records will be used confidentially and securely.

Who may be eligible?

To be included in this study, people must have been diagnosed with BPDCN and started their first chemotherapy treatment for it from May 2016 onwards. They need to be 18 years old or older at the time they started their first treatment.

The diagnosis of BPDCN needs to have been confirmed by specific tests, looking for certain markers on the cells. This study includes information from people who are still alive, have sadly passed away, or whose current contact details are unknown, as long as it's allowed by local rules and regulations.

People would not be included if they received a new, experimental drug as their first treatment for BPDCN, or if their first treatment was part of another study that was actively testing a new treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you diagnosed with BPDCN?
Did you start your first chemotherapy treatment for BPDCN from May 2016 onwards?
Was your first treatment standard chemotherapy, not an experimental drug in a trial?

Answer every question to see your result.

What does participation involve?

This is an 'observational' study, meaning it looks at information from your past medical records rather than asking you to change your current treatment or undergo new procedures. If you are eligible and agree to take part, you would not need to attend extra clinic visits or take any new medication. Your medical team would simply share information from your existing medical notes with the researchers, after you (or your legal representative) have given your consent. You would continue to receive your usual care from your own doctors. The study aims to collect information on treatments and outcomes over a period, but it does not require active participation from you once consent is given.

Potential risks and benefits

Taking part in this study does not involve any direct medical risks, as you would not be undergoing new treatments or tests specifically for the study. However, as with any research involving personal medical information, there's a very small risk to your privacy, which is minimised by ensuring your information is handled securely and kept confidential. The potential benefit is that the information gathered will help doctors better understand BPDCN and improve future treatments for others. Your participation is completely voluntary, and you have the right to withdraw your consent at any time without affecting your medical care.

Locations (67)

Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting
Centre Hospitalier Universitaire Besancon
Verified postcode
Besançon, France· Recruiting
Hôpital Avicenne
Verified postcode
Bobigny, France· Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque
Verified postcode
Bordeaux, France· Recruiting
Henri Mondor University Hospital
Verified postcode
Créteil, France· Recruiting
Centre Hospitalier Universitaire de Nice
Verified postcode
Nice, France· Recruiting
Saint-Antoine Hospital
Verified postcode
Paris, France· Recruiting
Saint-Louis Hospital
Verified postcode
Paris, France· Recruiting
Centre Hospitalier Universitaire Poitiers
Verified postcode
Poitiers, France· Recruiting
Centre Hospitalier Universitaire de Tours
Verified postcode
Tours, France· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is BPDCN?

BPDCN stands for Blastic Plasmacytoid Dendritic Cell Neoplasm. It's a very rare and aggressive type of blood cancer that affects certain immune cells.

Will I receive new treatment if I join this study?

No, this study only looks at treatments you have already received. It's not testing a new drug, and you won't get any new treatment through this study.

Do I need to visit the hospital more often for this study?

No, you don't need any extra hospital visits. The study collects information from your existing medical records.

Will my personal details be kept private?

Yes, all your personal information is handled with great care to protect your privacy, following strict regulations.

Who is funding this study?

The study is being run to provide comparison data for an existing registry study (STML-401-0521) which is likely sponsored by the company developing the ELZONRIS drug.

How to find out more

Stemline Trials

clinicaltrials@menarinistemline.com 1-877-332-796 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.