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An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

ConditionsHematologic MalignancySolid TumorAdvanced Malignancies
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Pelabresib

    Drug

    Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PelabresibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-emergent adverse events (TEAEs) and serious TEAEs

To evaluate long-term safety in patients who are receiving pelabresib

Time frame
5 years
2

Survival Follow-up

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.

Time frame
5 years
3

Duration of Response (DoR)

DOR defined as the time from the date of first response to the date of confirmed disease progression

Time frame
5 years
4

Progression-free survival (PFS)

PFS defined as the time from first dose to confirmed disease progression or death, whichever occurs first.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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