Active not recruitingPHASE1, PHASE2INTERVENTIONAL

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

This study is for adults aged 18 and over who have a specific type of blood cancer called Acute Myeloid Leukemia (AML) that has a marker called CD123. The main goal is to find out if a new drug called IMGN632 is safe and how well it works. Researchers are testing IMGN632 on its own, and also in combination with other existing AML medicines like Azacitidine and/or Venetoclax. Some patients in the study will be newly diagnosed, while others may have AML that has come back or not responded to previous treatments. The study aims to find the best dose and understand any side effects, as well as see if these treatments can help fight the cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AbbVie

Enrolment target

218

Start

06 Nov 2019

Estimated completion

01 Feb 2027

Acute Myeloid Leukemia

What is this study about?

This research study is looking into a new treatment called IMGN632 for adults affected by Acute Myeloid Leukemia (AML). AML is a blood cancer that starts in the bone marrow, the soft tissue inside your bones where blood cells are made. Researchers are particularly interested in AML that has a specific marker on the cancer cells, called CD123. This marker helps them identify which patients might benefit most from IMGN632.

The study is designed to answer important questions about IMGN632. Firstly, is it safe for patients to take? They're also trying to find the right dose of IMGN632, both when given on its own and when combined with other well-known AML medications like Azacitidine and Venetoclax. By combining old and new treatments, doctors hope to find more effective ways to fight AML.

This study includes different groups of patients. Some have AML that has come back after treatment or hasn't responded to earlier therapies. Other patients might be newly diagnosed and haven't had treatment before. The study has different stages, first finding the safest dose (Phase 1b) and then looking more closely at safety and how well the treatment works in a larger group of patients (Phase 2). This careful process helps doctors understand the potential of a new medicine before it becomes widely available.

Key takeaways

This study is testing a new drug, IMGN632, for AML.
It's for adults with CD123-positive AML.
IMGN632 is being tested alone and with other AML medicines.
The study aims to understand safety and effectiveness.
It's an early-stage study (Phase 1b/2).
Participation involves regular clinic visits and monitoring.

Who may be eligible?

To join this study, you must be 18 years old or older and have a confirmed diagnosis of Acute Myeloid Leukemia (AML). Your AML cells must also have a specific marker called CD123, which will be checked through a blood test.

Depending on which part of the study you might join, you could be someone who has been newly diagnosed and not yet treated, or your AML might have come back after previous treatment, or it might not have responded to earlier medicines. Some parts of the study are for patients whose cancer is in remission (meaning it's not active) but still shows signs of disease when checked very closely.

Your doctor will need to decide if this experimental treatment is right for you, especially considering any other treatments you've had. There are also limits on how many previous treatments you might have received. It's important to discuss your full medical history with your doctor to see if you meet all the criteria.

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 confirmed diagnosis of Acute Myeloid Leukemia (AML)?
Has your doctor confirmed your AML cells have the CD123 marker?
Are you able to attend regular clinic visits for treatment and check-ups?
Has your doctor discussed this experimental treatment with you and believes it could be suitable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either IMGN632 on its own, or IMGN632 combined with Azacitidine and/or Venetoclax. The specific treatment plan, including how often you receive the medication and for how long, will depend on the study group you are in. You will have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how the treatment is affecting you and your AML. These assessments help the doctors understand the treatment's safety and effectiveness. The total duration of your participation will vary depending on your treatment response and the specific part of the study, but it will involve ongoing follow-up for a period after treatment ends.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment (IMGN632) that isn't yet widely available and could potentially help fight your AML, especially if other treatments haven't worked or aren't suitable. However, as with any new medicine, there are potential risks and side effects that are not yet fully known or understood. These will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (29)

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

City of Hope National Medical Center /ID# 269273
Verified postcode
Duarte, United States
University Of California Irvine Medical Center /ID# 269275
Verified postcode
Orange, United States
Moffitt Cancer Center /ID# 269269
Verified postcode
Tampa, United States
Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 269642
Verified postcode
Chicago, United States
Dana-Farber Cancer Institute /ID# 269267
Verified postcode
Boston, United States
University of Michigan /ID# 269079
Verified postcode
Ann Arbor, United States
Mayo Clinic Hospital Rochester /ID# 269643
Verified postcode
Rochester, United States
Roswell Park Cancer Institute /ID# 269266
Verified postcode
Buffalo, United States
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 269271
Verified postcode
New York, United States
Duke University Health System /ID# 269268
Verified postcode
Durham, United States
Cleveland Clinic - Cleveland /ID# 269272
Verified postcode
Cleveland, United States
MD Anderson Houston /ID# 269265
Verified postcode
Houston, United States

Common questions

What is AML?

AML stands for Acute Myeloid Leukemia, which is a fast-growing cancer of the blood and bone marrow. It affects how your body makes healthy blood cells.

What does CD123-positive mean?

CD123 is like a specific flag found on the surface of some AML cancer cells. This study is for people whose AML cells have this particular flag.

Is IMGN632 a chemotherapy drug?

IMGN632 is a new type of drug that specifically targets cancer cells with the CD123 marker. It works differently from traditional chemotherapy, by delivering a powerful medicine directly to the cancer cells.

What are Azacitidine and Venetoclax?

These are existing medications commonly used to treat AML, and they work in different ways to help control or fight the cancer. This study is looking at combining them with IMGN632.

What does 'Phase 1b/2' mean?

This means the study is in the early stages. Phase 1b focuses on finding the safest dose of the new drug, and Phase 2 then looks more closely at how well it works and continues to check its safety in a larger group of people.