A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
This research trial is investigating a new medication called SY-1425 for adults living with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The main goal is to find out how effective SY-1425 is for patients who have certain genetic features (biomarkers) in their blood or bone marrow. This includes seeing if it helps improve their condition. Researchers are also carefully monitoring the safety of SY-1425, both when it's given on its own and when it's combined with other existing treatments like azacitidine or daratumumab. Participants will be closely observed for any side effects and changes in their health to ensure the treatment is well-tolerated. This is a Phase II trial, meaning it's an early stage of testing new medical treatments.
במבט חטוף
על מה המחקר הזה?
This study is a research trial exploring a new drug, SY-1425, for adults diagnosed with two types of blood cancer: acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). AML is a cancer of the blood and bone marrow, which are responsible for making blood cells. MDS is a condition where the bone marrow doesn't produce enough healthy blood cells. The researchers believe that SY-1425 might work particularly well for patients with specific genetic features, sometimes called 'biomarkers'. These biomarkers act like signposts that can help doctors predict how a patient might respond to a particular treatment.
The main aim of this trial is to see how successful SY-1425 is at treating these conditions, especially for those patients who have the identified biomarkers. They will look at whether the drug can improve the patient's condition, either by itself or when given alongside other established treatments like azacitidine or daratumumab. They are also very interested in understanding the safety of SY-1425 – what side effects it might cause and how well patients tolerate it.
By carefully studying these aspects, the researchers hope to learn if SY-1425 could be a helpful new treatment option for people with AML or MDS in the future. This kind of research is vital for developing new and more effective ways to fight these serious illnesses.
נקודות עיקריות
- This study is testing a new drug, SY-1425, for adults with AML or MDS.
- Researchers are particularly interested in how the drug works for patients with specific genetic 'biomarkers'.
- SY-1425 might be given alone or with other existing treatments like azacitidine.
- The main goals are to check how well the drug works and its safety.
- Participation involves regular clinic visits for checks, blood tests, and monitoring for side effects.
מי עשוי להיות זכאי?
This study is designed for adults who have been diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants must be at least 18 years old.
The research team will also check for specific genetic features, known as biomarkers, in your blood or bone marrow. This is because the new drug SY-1425 is thought to work best for people with these particular markers. Depending on your diagnosis and biomarker results, you might be suitable for different parts of the study.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 18 או יותר?
- Have you been diagnosed with Acute Myeloid Leukemia (AML)?
- Have you been diagnosed with Myelodysplastic Syndrome (MDS)?
- Are you willing to have tests to check for specific genetic markers (biomarkers)?
מה כרוך בהשתתפות?
If you decide to take part in this study, you would receive the study drug, SY-1425, potentially combined with other approved medications like azacitidine or daratumumab, depending on your specific situation. You will have regular visits to the clinic for medical check-ups, blood tests, and other assessments. These appointments will help the research team monitor how you are responding to the treatment and keep an eye on any side effects.
The specific schedule of visits and assessments will vary depending on which part of the study you are in and will be explained in detail by the study team. They will also collect samples (like blood or bone marrow) to learn more about your condition and how the drug is working. The total length of your participation will be discussed with you, but typically, clinical trials involve ongoing monitoring for a period after treatment too.
סיכונים ותועלות פוטנציאליים
מיקומים (1)
- —לא מאומתצרפת
שאלות נפוצות
What is AML and MDS?
AML (Acute Myeloid Leukemia) and MDS (Myelodysplastic Syndrome) are types of conditions that affect your bone marrow and blood cells. AML is a fast-growing cancer, while MDS means your bone marrow isn't making enough healthy blood cells.
What is SY-1425?
SY-1425 is a new medication being tested. It's designed to target specific features in cancer cells that are linked to AML and MDS, with the aim of treating these conditions.
מהם 'סמנים ביולוגיים'?
Biomarkers are specific signs or characteristics in your body, like certain gene changes in your blood or bone marrow cells. In this study, they help doctors understand if SY-1425 might be a suitable treatment for you.
האם אצטרך לשלם כדי להשתתף במחקר?
No, if you qualify and choose to participate, the study-related treatment and care will be provided at no cost to you.
מה אם אשנה את דעתי לאחר ההצטרפות?
אתה חופשי לעזוב את המחקר בכל עת, מכל סיבה שהיא, מבלי שזה ישפיע על הטיפול הרפואי שלך.
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תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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