Study of IMGN632, Venetoclax, and Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in patients whose cancer cells have a marker known as CD123. The study is testing a new treatment called IMGN632, which is being used alone or in combination with other medications. These medications include Venetoclax, also known by its code names ABT-199 and GDC-0199, and Azacitidine. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients with CD123-positive AML.

Participants in the study will receive different combinations of these treatments. Some will receive IMGN632 by itself, while others will receive it in combination with Venetoclax, Azacitidine, or both. The study will observe how well these treatments work in reducing the cancer and how the body tolerates them. The treatments will be given in different forms, such as tablets taken by mouth or infusions given through a vein.

The study will take place over several phases, starting with a phase to determine the best dose of IMGN632 when used with the other medications. This will be followed by a phase to see how effective the treatments are in fighting the cancer. The study aims to find out if these treatments can help patients who have not responded to previous treatments or who have not been treated before. The trial will also monitor for any side effects and how the treatments affect the cancer over time.

1 joining the study

Upon joining the study, the patient will be assigned to one of the treatment regimens based on their specific condition and medical history.

The study involves different regimens that include combinations of medications such as venetoclax, azacitidine, and IMGN632.

2 treatment regimen selection

The patient may be placed in one of the following regimens: Regimen A (IMGN632 with azacitidine), Regimen B (IMGN632 with venetoclax), Regimen C (IMGN632 with both azacitidine and venetoclax), or Regimen D (IMGN632 alone).

The selection is based on the patient’s specific type of leukemia and previous treatments.

3 medication administration

For Regimen A, the patient will receive azacitidine as a subcutaneous injection and IMGN632 as an intravenous infusion.

For Regimen B, the patient will take venetoclax orally in the form of film-coated tablets and receive IMGN632 intravenously.

For Regimen C, the patient will receive both azacitidine and venetoclax along with IMGN632.

For Regimen D, the patient will receive IMGN632 as a monotherapy.

4 treatment cycles

The treatment is administered in cycles, with each cycle lasting a specific period as determined by the study protocol.

The frequency and duration of medication administration depend on the assigned regimen and the patient’s response to treatment.

5 monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored through regular assessments.

These assessments may include blood tests, imaging studies, and evaluations of leukemia activity.

6 end of treatment

The study is expected to conclude by October 2025, at which point the patient’s participation in the trial will end.

The final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

Patient must be at least 18 years old.
Heart function must be at least 45% based on a test like an echocardiogram. This does not apply to certain patients who are considered unfit.
Patients who have had a bone marrow transplant can join if it was done more than 120 days ago, they don’t have active severe transplant-related issues, and they have stopped certain medications for at least 2 weeks.
Patients with a previous cancer can join if it is stable, and they finished treatment at least 6 months ago, with side effects mostly resolved.
Patients in certain groups must be unable to have intensive therapy, either because they are 75 or older, or have specific health issues if younger than 75.
Patients in certain groups must have a performance status, which measures daily living abilities, of 0 to 2 if 75 or older, or 0 to 3 if younger than 75.
Patients must have a confirmed diagnosis of Acute Myeloid Leukemia (AML), but not a specific type called acute promyelocytic leukemia.
Patients must have tried standard treatments and be considered suitable for this study by their doctor. Some patients who haven’t been treated before can join a specific part of the study.
Patients must have a type of AML that tests positive for a marker called CD123.
Patients may have had previous treatments targeting CD123, except for a specific drug called IMGN632, as long as CD123 is still detectable.
Patients in a specific part of the study must be in a certain remission state and have minimal residual disease (MRD) at screening, with no more than 2 previous treatments.
Patients must have a performance status of 1 or better, or a different measure of 70 or better if they have a chronic disability.
Previous treatment side effects must have mostly resolved.
White blood cell count must be below a certain level, and a medication called hydroxyurea can be used to control it before starting the study.
Liver enzymes must be no more than 3 times the normal limit.
Total bilirubin, a liver function measure, must be no more than 1.5 times the normal limit, with some exceptions for certain conditions.
Kidney function must be above a certain level, measured by a test called estimated glomerular filtration rate (eGFR) or creatinine clearance.

Who Cannot Join the Study?

Patients who do not have CD123 positive Acute Myeloid Leukemia cannot participate. This is a type of blood cancer that affects certain white blood cells.
Patients who are not within the specified age range cannot participate. The study is open to adults.
Patients who are not able to safely receive the study treatments due to other health conditions cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have certain infections or other serious health issues may not be eligible.
Patients who have had a recent heart attack or have severe heart problems may not be eligible.
Patients who have allergies to the study drugs or similar medications cannot participate.
Patients who are unable to follow the study procedures or attend required visits may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
MD Anderson Cancer Center	Madrid	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Imsocyko Rregtxllc Poz Le Sltdht Dyi Ticpgi Drfz Aawouck Iswe Sbxjap	Meldola	Italy
Urrzxeghtclubaylugmpy Mcialvyi Atv	Munster	Germany
Aofgdap Upylw Svhyeqomx Lwybfo Dq Bpeqctk	Bologna	Italy
Iiqtmfjz Plwlrhzyuuuxjjk Crvfsf Crfgpi	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.02.2020
Germany	Not recruiting	07.02.2020
Italy	Not recruiting	07.02.2020
Spain	Not recruiting	07.02.2020

Trial locations

Investigated drugs:

IMGN632 is an investigational medication being studied for its potential to treat acute myeloid leukemia (AML) that is positive for a specific marker called CD123. It is being tested both as a standalone treatment and in combination with other medications. The goal is to determine its safety, how well it is tolerated, and its effectiveness in reducing leukemia cells.

Azacitidine is a medication used in the treatment of certain types of blood cancers, including AML. It works by interfering with the growth of cancer cells, which may help to slow down or stop the progression of the disease. In this trial, it is being combined with other treatments to assess its effectiveness in enhancing the overall treatment outcome.

Venetoclax is a medication that targets and blocks a specific protein in cancer cells, which can lead to the death of these cells. It is used in the treatment of certain blood cancers, including AML. In this study, it is being used in combination with other medications to evaluate its potential to improve treatment results for patients with AML.

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the bone marrow, where blood cells are made, but often quickly moves into the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML can progress rapidly if not treated, leading to a decrease in the number of healthy blood cells. This can cause symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease is classified based on the specific genetic mutations and characteristics of the leukemia cells. CD123-positive AML refers to a subtype where the leukemia cells express a specific protein called CD123 on their surface.

Trial ID:

2024-514197-50-00

Protocol code:

IMGN632-0802

NCT ID:

NCT04086264

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of IMGN632, Venetoclax, and Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?