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A study to evaluate the efficacy of APG-2575 (Lisaftoclax) plus azacitidine (AZA) vs. placebo plus AZA in newly diagnosed adult subjects with higher risk myelodysplastic syndrome (Higher Risk-MDS).
EU CTIS ID: 2024-517247-31-00
What this study is testing
To evaluate the efficacy of xxx
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥ 18 years old.
- Newly Diagnosed MDS is defined according to 2022 World Health Organization classification (5th Edition)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy ≥ 3 months.
- Able to receive oral medication.
- Adequate organ functions as defined below: - Creatinine clearance ≥ 30 ml/min (calculated with Cockcroft formula, as shown in Annex 3) - Total bilirubin < 1.5 × ULN (except Gilbert's syndrome, hyperbilirubinemia due to regular blood transfusions as assessed by the investigator) - Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) ≤ 2.5 × ULN
You likely can't join if
- Previous diagnosis of xxx
- Any of the following cardiac abnormalities (as determined by the study physician based on clinical examination assessments): - Any history of myocardial infarction within 6 months - Congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) or left ventricular ejection fraction (LVEF) < 40% - Symptomatic ventricular arrhythmia uncontrolled by medication - Any history of familial long QT syndrome - The mean QT interval calculated from 3 electrocardiogram (ECG) readings (1 to 3 minutes apart) is > 470 (Using Fridercia's correction: QTcF = QT/RR0.33)
- Second malignancies or previous malignancies with a disease-free interval of less than 1 year at the time of signing the informed consent (except for subjects with adequately resected cutaneous basal cell or squamous cell carcinoma or resected carcinoma in situ).
- Have history of HSCT.
- Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection. (as determined by the study physician based on clinical examination assessments).
- Have malabsorption syndrome or other conditions and are not suitable for enteral drug administration.
See the full eligibility criteria
Who can join
- Aged ≥ 18 years old.
- Newly Diagnosed MDS is defined according to 2022 World Health Organization classification (5th Edition)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy ≥ 3 months.
- Able to receive oral medication.
- Adequate organ functions as defined below: - Creatinine clearance ≥ 30 ml/min (calculated with Cockcroft formula, as shown in Annex 3) - Total bilirubin < 1.5 × ULN (except Gilbert's syndrome, hyperbilirubinemia due to regular blood transfusions as assessed by the investigator) - Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) ≤ 2.5 × ULN
- Negative urine or serum pregnancy test prior to dosing in women of childbearing potential. Women of childbearing potential (postmenopausal women must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners are willing to use contraception as deemed effective by the investigator during treatment and for at least 6 months after the last dose of study drug.
- Subjects must have the ability to understand and voluntarily sign a written informed consent form that must be signed prior to performing any trial-specific study procedures.
- Subjects must be willing to participate in the study and are able to complete study procedures and follow-up examinations.
What rules you out
- Previous diagnosis of xxx
- Any of the following cardiac abnormalities (as determined by the study physician based on clinical examination assessments): - Any history of myocardial infarction within 6 months - Congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) or left ventricular ejection fraction (LVEF) < 40% - Symptomatic ventricular arrhythmia uncontrolled by medication - Any history of familial long QT syndrome - The mean QT interval calculated from 3 electrocardiogram (ECG) readings (1 to 3 minutes apart) is > 470 (Using Fridercia's correction: QTcF = QT/RR0.33)
- Second malignancies or previous malignancies with a disease-free interval of less than 1 year at the time of signing the informed consent (except for subjects with adequately resected cutaneous basal cell or squamous cell carcinoma or resected carcinoma in situ).
- Have history of HSCT.
- Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection. (as determined by the study physician based on clinical examination assessments).
- Have malabsorption syndrome or other conditions and are not suitable for enteral drug administration.
- Have any other conditions or illnesses which, in the investigator's judgment, makes them unsuitable for participation in this study, , including but not limited to; • Women who are breast feeding or planning to donate eggs within 6 months after the end of the study treatment • History of hypersensitivity to compounds related to lisaftoclax or AZA or to any of their excipients • History of bleeding disorders or active uncontrolled coagulopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Australia
- United States
- United Kingdom
- Canada
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Australia; United States; United Kingdom; Canada; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.