The purpose of this study is:
- To provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information
- To evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies
An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies with Pelabresib
The purpose of this study is to provide continued access to pelabresib treatment for patients who previously received pelabresib in a parent study and to continue collecting information on safety and efficacy.
By collecting efficacy and safety information, the study team will monitor the efficacy of pelabresib with regard to disease status and survival, as well as information on AEs, including SAEs and AEs of special interest (AESIs),
Additionally, survival follow-up data will be collected from patients who continued treatment with pelabresib in this extension study, and may also be collected from patients who discontinued treatment with placebo or pelabresib in pelabresib parent studies.
During the survival follow-up, the team will collect information on the leukaemia-free survival status and overall survival (lifespan) of the patient during and after the end of treatment.
If a patient discontinued pelabresib treatment in the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment in this extension study, but they can enter the study for survival-follow up only.
