An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Launched by NOVARTIS PHARMACEUTICALS · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is an extension study for patients who have already participated in earlier studies using a medication called pelabresib. The main goal of this trial is to allow those patients to continue receiving pelabresib while also gathering more information about how well it works and its safety. Researchers want to see if pelabresib helps manage patients' diseases, which can include blood cancers or solid tumors. They will also track how long patients live without their leukemia returning and their overall survival during and after treatment.

To be eligible for this study, patients need to have benefited from pelabresib in the earlier study and be willing to attend scheduled visits and follow the treatment plan. Patients must be at least 18 years old and able to give their consent. If someone stopped receiving pelabresib for reasons other than joining this study, they can still participate in follow-up evaluations to check their health status. It's important to note that certain individuals, such as those with serious health issues or who are pregnant, cannot join the study. Overall, this trial offers an opportunity for continued access to pelabresib and ongoing monitoring of patients' health.

Gender

ALL

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.