An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Condition(s) studied
Investigational drug(s) / intervention(s)
Pelabresib: Small molecule inhibitor of bromodomain and extraterminal (BET) protein
Study summary
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).
Eligibility
Primary outcome measure(s)
- Treatment-emergent adverse events (TEAEs) and serious TEAEs — 5 years
To evaluate long-term safety in patients who are receiving pelabresib - Survival Follow-up — 5 years
Survival Follow-up consists of Survival and Leukemia-Free Survival Follow-up. All participants in the extension study will be followed up for Survival, while participants with hematological malignancies will be followed up for Survival and Leukemia-Free Survival. In addition, participants who will not receive pelabresib treatment may enter this extension protocol to be only followed up for Survival. - Duration of Response (DoR) — 5 years
DOR defined as the time from the date of first response to the date of confirmed disease progression - Progression-free survival (PFS) — 5 years
PFS defined as the time from first dose to confirmed disease progression or death, whichever occurs first. - Leukemia-free survival (LFS) — 5 years
LFS defined as the time from first dose to the date of leukemic transformation or death, whichever occurs first.
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California LA | Los Angeles | California | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| Uni Of Michigan Health System | Ann Arbor | Michigan | Recruiting |
| New York Presbyterian Hospital | New York | New York | Recruiting |
| Mt Sinai Medical Center | New York | New York | Recruiting |
| Novartis Investigative Site | Antwerp | Belgium | Recruiting |
| Novartis Investigative Site | Bruges | Belgium | Recruiting |
| Novartis Investigative Site | Florence | FI | Recruiting |
| Novartis Investigative Site | Varese | VA | Recruiting |
| Novartis Investigative Site | Novara | Italy | Recruiting |
| Novartis Investigative Site | Amsterdam | Netherlands | Recruiting |
| Novartis Investigative Site | Cardiff | United Kingdom | Recruiting |
| Novartis Investigative Site | Glasgow | United Kingdom | Recruiting |
| Novartis Investigative Site | London | United Kingdom | Recruiting |
More Novartis Pharmaceuticals trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06401356 on ClinicalTrials.gov ↗ ← All trials in the UK