Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

This study is investigating a new medication called IMGN632 for individuals with specific blood cancers. This includes a rare condition known as Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), as well as some other blood cancer types that have come back or not responded to previous treatments. The study aims to understand the highest safe dose of IMGN632, check for any side effects, and see if it can effectively reduce the cancer. Participants will receive the medicine directly into a vein every three weeks. This research could help us learn more about treating these challenging blood cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AbbVie

Enrolment target

179

Start

02 Jan 2018

Estimated completion

30 Dec 2026

Blastic Plasmacytoid Dendritic Cell Neoplasm Myeloproliferative Neoplasm

What is this study about?

This study is looking into a new treatment called IMGN632 for certain types of blood cancers. One of the main focuses is a rare and serious blood cancer called Blastic Plasmacytoid Dendritic Cell Neoplasm, often shortened to BPDCN. We are also exploring its use in other blood cancers that have either returned after treatment or haven't responded well to usual therapies. The goal is to see if IMGN632 is safe, how well people tolerate it, and if it can help fight the cancer.

IMGN632 is a type of medicine that targets specific cells. In this study, it's designed to act on cancer cells that have a particular marker called CD123 on their surface. By targeting this marker, the hope is that the treatment can destroy cancer cells while leaving healthy cells as unharmed as possible. The study is divided into two parts, what scientists call Phase 1 and Phase 2. Phase 1 usually involves a smaller group of people and focuses on finding the best and safest dose. Phase 2 then looks at how well the treatment works in a larger group.

Taking part in a study like this means you would receive IMGN632 directly into your vein on the first day of a three-week cycle. This treatment would continue over several cycles. By participating, you would be helping doctors and researchers learn more about new ways to treat these types of blood cancers, potentially leading to new options for patients in the future.

Key takeaways

This study is for a new drug, IMGN632, for certain blood cancers.
It focuses on a rare cancer called BPDCN, and other recurring blood cancers.
The drug targets a marker called CD123 on cancer cells.
Participants receive treatment directly into a vein every three weeks.
The study aims to understand safety, side effects, and how well the drug works.
Participation helps advance understanding of these challenging cancers.

Who may be eligible?

This study is for adults, aged 18 and over, who have certain types of blood cancers where the cancer cells have a specific marker called CD123. This includes people with BPDCN that has either just been diagnosed (and they haven't had prior general treatment for it) or has come back after treatment. It also includes people with other blood cancers like AML (a type of leukaemia) or MDS (a bone marrow condition) that have come back or haven't responded well to previous treatments.

To be considered, your doctors will need to confirm that your cancer cells have the CD123 marker. If you have BPDCN that has spread to your brain or spinal cord, you might not be able to join, especially if it's a new diagnosis. However, if BPDCN in your brain or spinal cord has been treated and is stable, you could still be eligible.

Generally, if there are already standard and effective treatments available for your specific condition, you might not be able to join some parts of this study. The study aims to help those for whom current treatments haven't worked or who have a newly diagnosed rare condition.

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?
Do you have a diagnosis of BPDCN, or another specific blood cancer that has come back or not responded to treatment?
Has it been confirmed that your cancer cells have the CD123 marker?
Have you not had prior general treatment for newly diagnosed BPDCN? (If applicable)
If your cancer has spread to your brain/spinal cord, has it been treated and is stable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, IMGN632, through a drip into your arm (intravenously) on the first day of each treatment cycle. Each cycle lasts for 21 days, meaning you would receive the treatment every three weeks. During the study, you would have regular visits to the hospital or clinic. These visits would include check-ups, blood tests, and other assessments to see how you are responding to the treatment and to monitor for any side effects. The medical team will closely watch your health throughout your time in the study. The total duration of your participation would depend on how you respond to the treatment and would be discussed with you in detail by the study doctor.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new treatment that isn't yet available generally. While this treatment may or may not help your specific condition, your participation will provide valuable information that could help others in the future. However, there are also potential risks involved. New medicines can have side effects, and some may be serious. The doctors and nurses will closely monitor you for any side effects and will explain all known risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Banner Health MD Anderson Cancer Center
Verified postcode
Gilbert, United States
City of Hope Medical Center
Verified postcode
Duarte, United States
UCLA
Verified postcode
Los Angeles, United States
Stanford
Verified postcode
Stanford, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
University of Maryland Medical Center
Verified postcode
Baltimore, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Roswell Park Cancer Institute
Verified postcode
Buffalo, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Novant Health Cancer Institute Hematology
Verified postcode
Charlotte, United States
Duke Cancer Institute
Verified postcode
Durham, United States
Novant Health Cancer Institute Hematology - Forsyth
Verified postcode
Winston-Salem, United States

Common questions

What is BPDCN?

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

What does 'relapsed or refractory' mean?

It means the cancer has either come back after previous treatment (relapsed) or hasn't responded to earlier treatments (refractory).

What is CD123?

CD123 is a specific marker, like a flag, found on the surface of some cancer cells, including in BPDCN. The study drug targets cells with this marker.

Will I get the new drug or a dummy pill?

In this study, everyone who participates will receive the active study drug, IMGN632. There is no dummy pill (placebo) used.

How often will I need to visit the hospital?

You'll receive treatment every three weeks, so you'll have regular visits for your medication and check-ups. The exact schedule will be explained by the study team.