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Sabatolimab

Sabatolimab clinical trials are studying continued treatment in adults with certain blood cancers, including higher-risk myelodysplastic syndromes and acute myeloid leukemia. These trials mainly look at safety and whether patients may continue to benefit from treatment after a prior study.

Table of Contents

Trial overview

The source data describe one interventional study, which means the research team gives a treatment and follows what happens next.[1] This study is a roll-over study for people who already finished a prior Novartis-sponsored Sabatolimab study and are judged by the investigator to still benefit from treatment.[1]

The study is authorised and has the trial ID NCT05201066.[1] It is planned for 45 participants.[1]

Who is being studied

The trial targets adults with intermediate, high, or very high risk myelodysplastic syndromes (MDS), adults with chronic myelomonocytic leukemia – 2 (CMML-2), and adults with acute myeloid leukemia (AML) who are unfit for chemotherapy.[1]

In simple terms, this means the study focuses on adults with serious blood diseases, including people whose disease risk is higher and people who cannot safely receive standard chemotherapy.[1] The trial also includes patients who completed a previous Sabatolimab study and may continue to benefit from treatment.[1]

Study design and phase

This is a Phase 2 study.[1] Phase 2 trials usually look at safety and early signs of benefit in a specific patient group, and this source data mainly highlight safety.[1]

The interventions listed in the source include Sabatolimab, also named MBG453, and other treatments such as venetoclax and azacitidine.[1] The trial title and summary make clear that the main purpose is continued treatment with Sabatolimab after a prior study.[1]

What the trial measures

The primary outcome is the frequency and severity of adverse events (AEs) and serious adverse events (SAEs).[1] In patient-friendly language, the study checks how often unwanted medical problems happen and how serious they are.[1]

The brief summary says the study aims to evaluate safety, including SAE and AE.[1] No other endpoints are listed in the source data provided.[1]

Trial summary

Overall, the available trial data describe one authorised Phase 2 roll-over study of Sabatolimab in adults with higher-risk blood cancers.[1] The trial is focused on continued treatment after a previous study and is centered on safety monitoring.[1] The main question is whether patients who may still benefit can keep receiving study treatment safely.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05201066 Phase 2 Intermediate, high, or very high risk MDS; CMML-2; AML in adults unfit for chemotherapy Authorised 45

FAQ

  • What is being studied in Sabatolimab clinical trials? The trial data focus on continued treatment with Sabatolimab in patients who finished a previous study and may still benefit. The main goal is to check safety, especially side effects and serious side effects.
  • Who may be able to join these trials? Adults with intermediate, high, or very high risk myelodysplastic syndromes, adults with CMML-2, and adults with acute myeloid leukemia who are unfit for chemotherapy are the target groups. One study also includes people who completed a prior Novartis-sponsored Sabatolimab study.
  • What phase is the Sabatolimab trial? The trial listed in the source data is a Phase 2 study. Phase 2 trials usually look at both safety and early signs of benefit in a specific patient group.
  • What outcomes are measured in the trial? The main outcome is the frequency and severity of adverse events and serious adverse events. In simple terms, the study checks how often unwanted medical problems happen and how serious they are.
  • Is Sabatolimab being studied as a new treatment or a continuation study? This trial is a roll-over study, which means it is for patients who already completed a prior Sabatolimab study. The investigator must judge that the patient may benefit from continuing treatment.

Ongoing Clinical Trials on Sabatolimab

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Greece Italy Spain

Glossary

  • Adverse events (AEs): Medical problems or unwanted effects that happen during a study, whether or not they are caused by the study treatment.
  • Serious adverse events (SAEs): More severe medical problems in a trial, such as events that are life-threatening, require hospital care, or cause major harm.
  • Phase 2: A trial stage that usually checks safety and looks for early signs that a treatment may help a specific group of patients.
  • Roll-over study: A study that allows patients who finished a previous trial to keep receiving the study treatment if the investigator thinks they may still benefit.
  • Myelodysplastic syndromes (MDS): A group of blood disorders where the bone marrow does not make healthy blood cells normally.
  • Intermediate risk: A middle level of disease risk. In this trial, it refers to patients with MDS who are not in the lowest-risk group.
  • High risk: A higher level of disease risk, meaning the condition is more likely to worsen or cause serious problems.
  • Very high risk: The highest level of disease risk listed in the trial data for MDS.
  • Chronic myelomonocytic leukemia (CMML-2): A type of blood cancer. CMML-2 is a more advanced form of this disease.
  • Acute myeloid leukemia (AML): A fast-growing blood cancer that affects the bone marrow and blood.
  • Unfit for chemotherapy: Not able to safely receive standard chemotherapy because of health or medical reasons.
  • Enrollment: The number of people planned to join a trial.

References