An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

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

Sponsors and collaborators