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S227928

Clinical trials are investigating S227928 in people with hard-to-treat blood cancers. The studies look at safety, tolerability, dose finding, and early signs of benefit, both alone and with venetoclax. The main groups include patients with relapsed or refractory AML, MDS/AML, and CMML.

Table of contents

Trial overview

The clinical trial NCT06563804 studied S227928 in people with relapsed or refractory blood cancers.[1] It was a Phase 1/2 interventional study, which means the treatment was given to participants and then checked for safety and early signs of benefit.[1] The trial was completed and enrolled 123 participants.[1]

Who was studied

The study focused on patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome/AML (MDS/AML), or chronic myelomonocytic leukemia (CMML).[1] Relapsed means the disease came back after treatment, and refractory means it did not respond well to earlier treatment.[1] The Phase 2 part was split into two groups: cohort 1 for R/R AML or MDS/AML, and cohort 2 for R/R CMML.[1]

What the study measured

In Phase 1, the main goals were to assess safety and tolerability, and to find the maximum tolerated dose, if appropriate.[1] The study also measured dose-limiting toxicities (DLTs), which are side effects serious enough to limit treatment.[1] Other Phase 1 measures included adverse events, serious adverse events, changes in vital signs, physical examination findings, laboratory tests, cardiac markers, ECG, echocardiogram with or without GLS or MUGA, and cardiac MRI.[1] The study also tracked dose reductions, interruptions, delays, or withdrawal because of adverse events.[1]

In Phase 2, the main outcome was complete remission (CR).[1] This means the researchers wanted to see whether the treatment could remove clear signs of disease based on the study rules.[1] The brief summary also says Phase 2 was designed to assess anti-leukemic activity in the two patient cohorts.[1]

Study design and treatment groups

The study tested S227928 as a single agent and also in combination with venetoclax.[1] In simple terms, single agent means the drug was studied by itself, while combination means it was studied together with another treatment.[1] The intervention list also included supportive medicines and infusion-related products used in the study setting, such as venetoclax tablets, Zyloric, and Fasturtec.[1]

Results notes from the trial record

The trial record provided here describes the study design, target diseases, and main outcome measures, but it does not give detailed final efficacy results.[1] Because the study is marked completed, the record shows that the planned testing phase has ended, but the source data here do not include a full outcome report.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06563804 Phase 1/2 Relapsed/refractory AML, MDS/AML, or CMML Completed 123

FAQ

  • What is being studied in the S227928 trials? The trials are studying S227928 as a single treatment and together with venetoclax. They are looking at safety, the best dose, and whether the treatment helps control the cancer.
  • Who can take part in these studies? The main study groups are adults with relapsed or refractory acute myeloid leukemia, MDS/AML, or chronic myelomonocytic leukemia. These are cancers that have come back or did not respond well to earlier treatment.
  • What trial phase is S227928 being tested in? The study is in Phase 1/2. Phase 1 focuses on safety and dose finding, while Phase 2 looks more closely at whether the treatment works.
  • What results are the researchers measuring? They are measuring dose-limiting toxicities, other side effects, changes in tests such as ECG and heart scans, and whether people need dose changes or stop treatment. In Phase 2, they are looking for complete remission.
  • What does complete remission mean in this trial? Complete remission means there are no clear signs of the cancer after treatment, based on the study’s rules. It is one of the main measures of anti-leukemia activity in Phase 2.

Ongoing Clinical Trials on S227928

  • Study of S227928 Alone and with Venetoclax for Patients with Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Germany

Glossary

  • Acute myeloid leukemia (AML): A fast-growing cancer of the blood and bone marrow. In these trials, people have AML that has returned or did not respond to earlier treatment.
  • Relapsed/refractory (R/R): Relapsed means the disease came back after treatment. Refractory means the disease did not respond well to treatment.
  • Myelodysplastic syndrome (MDS)/AML: A blood disorder that can overlap with AML. In this study, it refers to patients whose disease has features of both conditions.
  • Chronic myelomonocytic leukemia (CMML): A type of blood cancer that affects cells made in the bone marrow. It is one of the target conditions in the trial.
  • Phase 1: The early part of a clinical trial. It mainly checks safety, side effects, and the best dose to use.
  • Phase 2: A later trial stage that looks more closely at whether the treatment helps the disease.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much of a treatment can be given.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event (SAE): A medical problem during the study that is severe, life-threatening, or needs hospital care.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity.
  • Echocardiogram (ECHO): An ultrasound test that shows how the heart is working.
  • Complete remission (CR): A trial result meaning there are no clear signs of cancer after treatment, based on the study’s criteria.

References