An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

CNST0610C210

The purpose of this study is to provide continued access to treatment with pelabresib for patients who previously received pelabresib in a parent study and to continue collecting safety and efficacy information. By collecting efficacy information, the study team monitors if pelabresib helps the patient with their disease. Additionally, survival follow-up data will be collected. Survival follow-up collects information on the patient's leukemia-free survival and overall survival status (life span) during and after the treatment is ended. If a patient stopped pelabresib treatment on the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment, but they can enter the study for survival-follow up only.

2024-06-01

2024-06-30

2024-06-30

Not yet recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-05-06