Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06401356
Eligibility Criteria:
Inclusion 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.
Note: Women with amenorrhea due to chemo/radiotherapy are considered WOCBP and must use contraception.
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.
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06401356
Study Brief:
Protocol Section:
NCT06401356