NCT06401356 An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Trial Parameters

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Brief Summary

The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).

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

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