About this trial

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 criteria

Qualifiers

Eligibility for Ongoing Pelabresib Treatment

Able to provide signed informed consent, agreeing to all protocol and ICF requirements.

At least 18 years old and legally able to consent in the study's jurisdiction.

Previously enrolled and currently receiving pelabresib in a parent study.

Disqualifiers

Eligibility for Ongoing Pelabresib Treatment

Legally institutionalized or under judicial protection.

Enrolled in another interventional clinical trial (excluding the parent study).

History of hypersensitivity to pelabresib, its excipients, or similar drugs.

Trial design

Treatments tested in this trial

  • Pelabresib

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

15
Belgium
Novartis Investigative Site2030, Antwerp Belgium
Novartis Investigative Site8000, Bruges Belgium
Italy
Novartis Investigative Site50134, FlorenceFI, Italy
Novartis Investigative Site21100, VareseVA, Italy

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor