Actively Recruiting
An Open-Label, Multicenter, 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and clinical benefits of pelabresib, a small molecule inhibitor targeting bromodomain and extraterminal (BET) proteins, in patients with hematological and/or solid tumors or advanced malignancies. This Phase 3 open-label extension study also includes participants previously enrolled in pelabresib studies who received placebo or discontinued treatment for reasons other than participation in this extension. The study aims to assess survival, leukemia-free survival for hematological malignancies, and overall survival follow-up for other patients. Eligible participants will continue pelabresib treatment at the same dose and schedule as their parent study unless dose adjustments are needed for toxicity. Those who discontinued pelabresib or received placebo may join for survival follow-up only. The study includes an eligibility check period of up to 28 days, followed by ongoing treatment and assessment. After treatment ends, patients will enter a safety follow-up period lasting about 30 days, monitoring for adverse events and serious adverse events. Treatment may continue as long as it is tolerated and criteria for discontinuation are not met. Participants will undergo regular visits as defined in the study schedule, including assessments of disease status, survival, and safety. If patients cannot return for safety visits, they will be contacted by phone to review any adverse events. The study continues until all parent studies have closed and the last patient has permanently discontinued investigational pelabresib and completed safety follow-up or is lost to follow-up, deceased, or has withdrawn consent. The primary outcomes include treatment-emergent adverse events, survival, duration of response, progression-free survival, and leukemia-free survival over five years.
CONDITIONS
Brief 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 agreeing to protocol and study requirements
- At least 18 years old and legally able to consent
- Previously enrolled and currently receiving pelabresib in a parent study
- Demonstrating clinical benefit from pelabresib as judged by the investigator
- Willing and able to follow all study visits, treatments, and procedures
- Agree to use effective contraception if of childbearing potential (men and women) and comply with pregnancy testing and avoidance of breastfeeding as specified
- 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 (excluding parent study)
- History of hypersensitivity to pelabresib or similar drugs
- Significant gastrointestinal conditions affecting drug absorption
- Any medical condition or uncontrolled illness unsuitable for study participation
- Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose
- Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose
- Used strong CYP3A4 inhibitors/inducers within 2 weeks before first dose or during treatment
- Female participants who are pregnant, breastfeeding, or not using required contraception
- Male participants not agreeing to contraception or sperm donation restrictions
- Unwilling or unable to comply with study protocol
- For survival follow-up: legally institutionalized or under judicial protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - As long as the regimen is tolerated and discontinuation criteria are not met
Participants continue treatment with pelabresib as administered in the relevant parent study.
Visits as per parent study dosing schedule
Duration - 30 days (±3 days)
Participants are monitored for adverse events for 30 days after the last dose of pelabresib or until starting new anticancer therapy.
1 visit (in-person or telephone)
Duration - Up to 5 years
Participants are followed for survival outcomes for up to 5 years after treatment completion.
Follow-up visits or contacts as scheduled
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
N
Novartis Pharmaceuticals
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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