An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Eligibility Criteria

• 1. Eligibility for Ongoing Pelabresib Treatment
• * Able to provide signed informed consent, agreeing to all protocol and ICF requirements.
• * At least 18 years old and legally able to consent in the study's jurisdiction.
• * Previously enrolled and currently receiving pelabresib in a parent study.
• * Demonstrating clinical benefit from pelabresib, as judged by the investigator.
• * Willing and able to follow all study visits, treatments, and procedures.
• * Agree to avoid pregnancy or fathering children:
• * Men: Must use highly effective contraception (≥99% effective) and avoid sperm donation from eligibility check through 94 days post-treatment.
• * Women of childbearing potential (WOCBP): Must test negative for pregnancy at eligibility, use highly effective contraception through 184 days post-treatment, undergo regular pregnancy testing, and avoid breastfeeding and oocyte donation during this period.
• * Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible.
• 2. Eligibility for Survival Follow-up
• * Provide signed informed consent, agreeing to all protocol and ICF requirements.
• * Are at least 18 years old and legally able to consent.
• * Were previously enrolled in a pelabresib clinical study.
• * Are willing and able to comply with follow-up procedures.
• 1. Eligibility for Ongoing Pelabresib Treatment
• * Legally institutionalized or under judicial protection.
• * Enrolled in another interventional clinical trial (excluding the parent study).
• * History of hypersensitivity to pelabresib, its excipients, or similar drugs.
• * Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption.
• * Any medical condition deemed unsuitable by the investigator.
• * Uncontrolled illness or condition that may compromise safety or protocol compliance.
• * Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose. (Hydroxyurea/anagrelide allowed up to 24 hours prior.)
• * Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.
• * Used strong CYP3A4 inhibitors/inducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited.
• * Female participants who are pregnant, breastfeeding, or not using required contraception.
• * Male participants who do not agree to use contraception or refrain from sperm donation as specified.
• * Unwilling or unable to comply with the study protocol.
• 2. Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.