Study on Continued Treatment with Sabatolimab for Adults with High-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Unfit for Chemotherapy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called sabatolimab (also known by its code name MBG453) in patients with certain blood-related diseases. These diseases include Myelodysplastic Syndromes (MDS), which are conditions where the bone marrow does not produce enough healthy blood cells, Chronic Myelomonocytic Leukemia (CMML-2), a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood, and Acute Myeloid Leukemia (AML), a cancer of the blood and bone marrow characterized by an excess of immature white blood cells. The study is specifically for adult patients who are not suitable for chemotherapy.

The purpose of this study is to evaluate the safety of continuing treatment with sabatolimab for patients who have already participated in a previous study involving this medication and are considered by their doctors to benefit from ongoing treatment. The study will monitor the frequency and severity of any side effects experienced by the participants. Participants will receive sabatolimab through an intravenous infusion, which means the medication is given directly into a vein.

In addition to sabatolimab, the study may involve other medications such as azacitidine, a drug used to treat certain types of blood disorders, and venetoclax, a medication that helps to kill cancer cells by blocking a protein that allows them to survive. Azacitidine is administered as a powder mixed into a liquid for injection, while venetoclax is taken orally as a tablet. The study will continue for a period of up to 60 months, during which the participants’ health and response to the treatment will be closely monitored by the research team.

1 enrollment in the roll-over study

Enrollment in the roll-over study occurs after completing a previous study with sabatolimab. Eligibility is determined by the investigator based on the benefit from continued treatment.

Written informed consent is required before joining the roll-over study.

2 treatment with sabatolimab

Sabatolimab is administered through intravenous use. The frequency and dosage are determined by the investigator based on individual needs and previous treatment response.

The treatment continues as long as there is a perceived benefit and safety is maintained.

3 monitoring and evaluation

Regular visits are scheduled to monitor the safety and effectiveness of sabatolimab. This includes evaluating any side effects or adverse events.

The duration of exposure to sabatolimab is recorded to assess long-term benefits and risks.

4 completion of the study

The study is estimated to end by February 14, 2028. Participation continues until this date or until the investigator decides that the treatment is no longer beneficial.

Upon completion, a final evaluation is conducted to summarize the treatment outcomes and any side effects experienced.

Who Can Join the Study?

The participant must already be enrolled in a study sponsored by Novartis that involves a treatment called sabatolimab.
The participant must be currently receiving treatment with sabatolimab and meeting all the requirements of the original study.
The participant must be benefiting from the sabatolimab treatment, as determined by the study guidelines and the judgment of the study doctor.
The participant must have shown that they are following the rules and requirements of the original study, as assessed by the study doctor.
The participant must be willing and able to attend scheduled visits, follow the treatment plan, and participate in any other study procedures.
The participant must provide written informed consent before joining the new study. This means they agree to participate after being informed about the study details.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied.
Patients who are currently receiving treatment that might interfere with the study.
Patients who have a serious medical condition that could make participating in the study unsafe.
Patients who are pregnant or breastfeeding.
Patients who have had a recent surgery or are planning to have surgery soon.
Patients who have a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or attend study visits.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Universitaet Leipzig	Leipzig	Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
General University Hospital Of Patras	Patras	Greece
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Universita Degli Studi Di Brescia	Brescia	Italy
Iveskejh Cylocc Dnodhjqlsivjibioy	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	13.02.2023
France	Not recruiting	13.02.2023
Germany	Not recruiting	13.02.2023
Greece	Not recruiting	13.02.2023
Italy	Not recruiting	13.02.2023
Spain	Not recruiting	13.02.2023

Trial locations

Investigated drugs:

Sabatolimab (MBG453) is a medication being studied for its potential benefits in treating certain conditions. In this trial, patients who have previously participated in a study involving sabatolimab and are considered by their doctors to benefit from continued treatment will receive this medication. The main goal is to assess the safety of sabatolimab, including any serious or non-serious side effects that may occur during the treatment.

Investigated diseases:

Myelodysplastic Syndromes (MDS) – These are a group of disorders caused by poorly formed or dysfunctional blood cells. In intermediate, high, or very high risk MDS, the bone marrow does not produce enough healthy blood cells, leading to anemia, infections, or bleeding. Over time, MDS can progress to more severe forms, potentially transforming into acute myeloid leukemia. The disease is characterized by the presence of immature blood cells in the bone marrow and blood. Patients may experience fatigue, weakness, and other symptoms related to low blood counts.

Chronic Myelomonocytic Leukemia (CMML-2) – This is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. CMML-2 is characterized by an increased number of monocytes, a type of white blood cell, in the blood and bone marrow. It is a more advanced form of CMML, with a higher percentage of immature cells. The disease can cause symptoms such as fatigue, fever, and weight loss. Over time, CMML-2 may progress to acute myeloid leukemia.

Acute Myeloid Leukemia (AML) – This is a fast-growing cancer of the blood and bone marrow. 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 cause symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention. In patients unfit for chemotherapy, the disease may be managed with alternative treatments.

Trial ID:

2024-515281-14-00

Protocol code:

CMBG453B12206B

NCT ID:

NCT05201066

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Continued Treatment with Sabatolimab for Adults with High-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Unfit for Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?