Actively Recruiting
An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Led by Novartis Pharmaceuticals · Updated on 2025-06-22
50
Participants Needed
15
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and agree to study requirements.
- At least 18 years old and legally able to consent.
- Previously enrolled and currently receiving pelabresib in a parent study.
- Showing clinical benefit from pelabresib as judged by the investigator.
- Willing and able to follow all study visits, treatments, and procedures.
- Men must use highly effective contraception and avoid sperm donation from eligibility through 94 days post-treatment.
- Women of childbearing potential 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 for at least 12 months) are eligible.
- Provide signed informed consent and agree to follow-up procedures for survival follow-up.
- Previously enrolled in a pelabresib clinical study and willing to comply with follow-up procedures.
You will not qualify if you...
- Legally institutionalized or under judicial protection.
- Enrolled in another interventional clinical trial (except parent study).
- History of hypersensitivity to pelabresib or similar drugs.
- Significant gastrointestinal issues affecting drug absorption (e.g., active inflammatory bowel disease, unresolved nausea/vomiting/diarrhea above Grade 1).
- Any medical condition deemed unsuitable by the investigator.
- Uncontrolled illness or condition that compromises safety or protocol compliance.
- Received systemic anticancer or investigational treatment (except parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose (hydroxyurea/anagrelide allowed up to 24 hours prior).
- Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.
- Used strong CYP3A4 inhibitors or inducers within 2 weeks before first dose; prohibited during treatment.
- Female participants who are pregnant, breastfeeding, or not using required contraception.
- Male participants who do not agree to use contraception or refrain from sperm donation as specified.
- Unwilling or unable to comply with the study protocol.
- Legally institutionalized or under judicial protection for survival follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)
Los Angeles, California, United States, 90095-8344
Actively Recruiting
2
Mayo Clinic (Cancer Clinical Research Office)
Jacksonville, Florida, United States, 32224-1865
Actively Recruiting
3
Northwestern Memorial Hospital (Oncology)
Chicago, Illinois, United States, 60611-5957
Actively Recruiting
4
UMHS - University of Michigan Medical Center (Radiation Oncology)
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
5
Mount Sinai Hospital - Oncology
New York, New York, United States, 10029
Actively Recruiting
6
Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)
New York, New York, United States, 10065
Actively Recruiting
7
ZNA Cadix-Hematology
Antwerp, Belgium, 2020
Actively Recruiting
8
Az St-Jan Brugge-Oostende A.V.
Bruges, Belgium, 8000
Actively Recruiting
9
AOU Careggi (Department of Experimental and Clinical Medicine)
Florence, Italy, 50141
Actively Recruiting
10
Azienda Ospedaliero - Universitaria Maggiore della Carità (SCDU Ematologia)
Novara, Italy, 28100
Enrolling by Invitation
11
AO Ospedale di Circolo, PO Varese (Ematologia)
Varese, Italy, 21100
Actively Recruiting
12
Amsterdam UMC location Vumc (Hematology)
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
13
Cardiff and Vale University Health Board - University Hospital Wales (Hematology)
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
14
Beatson West of Scotland Cancer Centre (Hematology)
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
15
Guys and St Thomas' Hospital - Haematology
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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