Study Description
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 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.
Interventions
Pelabresib
Eligibility Criteria
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
Az St-Jan Brugge-Oostende A.V.
Recruiting
Brugge,8000,Belgium
ZNA Cadix-Hematology
Recruiting
Antwerpen,2020,Belgium
AOU Careggi (Department of Experimental and Clinical Medicine)
Recruiting
Firenze,50141,Italy
AO Ospedale di Circolo, PO Varese (Ematologia)
Recruiting
Varese,21100,Italy
Amsterdam UMC location Vumc (Hematology)
Recruiting
Amsterdam,1081 hv,Netherlands
Guys and St Thomas' Hospital - Haematology
Recruiting
London,Se1 9rt,United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales (Hematology)
Recruiting
Cardiff,Cf14 4xw,United Kingdom
Beatson West of Scotland Cancer Centre (Hematology)
Recruiting
Glasgow,G12 0yn,United Kingdom
Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)
Recruiting
Los Angeles,California,90095-8344,United States
Mayo Clinic (Cancer Clinical Research Office)
Recruiting
Jacksonville,Florida,32224-1865,United States
Northwestern Memorial Hospital (Oncology)
Recruiting
Chicago,Illinois,60611-5957,United States
UMHS - University of Michigan Medical Center (Radiation Oncology)
Recruiting
Ann Arbor,Michigan,48109-5000,United States
Mount Sinai Hospital - Oncology
Recruiting
New York,New York,10029,United States
Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)
Recruiting
New York,New York,10065,United States
Worldwide Contacts
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