An Extension Study for Patients Previously Enrolled in Studies with Pelabresib

ID#: NCT06401356

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 13, 2024

End Date: June 30, 2029

Contact Information:
Medical Information
+1 844 667-1992
Summary:

The purpose of this study is: 1. To provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information 2. To evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies

Eligibility:



Inclusion Criteria: Eligibility for Ongoing Pelabresib Treatment

1. Capable of giving signed informed consent

2. Receiving clinical benefit from treatment with pelabresib in the parent study

3. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Capable of giving signed informed consent Patient must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF

2. Patient has been enrolled in a clinical study with pelabresib

3. Willingness and ability to comply with ongoing follow-up as indicated in this protocol

Exclusion Criteria: Eligibility for Ongoing Pelabresib Treatment

1. Patients who are legally institutionalized or under judicial protection

2. Any medical condition that, in the investigator's opinion, makes the patient unsuitable for the study

3. Patient is able to access pelabresib outside the study

4. Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol

5. Female patients who are pregnant or breastfeeding Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Patients who are legally institutionalized or under judicial protection