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RECRUITING
NCT06401356
PHASE3

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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).

Official title: An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-08-13

Completion Date

2027-06-30

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

DRUG

Pelabresib

Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Locations (15)

Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)

Los Angeles, California, United States

Mayo Clinic (Cancer Clinical Research Office)

Jacksonville, Florida, United States

Northwestern Memorial Hospital (Oncology)

Chicago, Illinois, United States

UMHS - University of Michigan Medical Center (Radiation Oncology)

Ann Arbor, Michigan, United States

Mount Sinai Hospital - Oncology

New York, New York, United States

Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)

New York, New York, United States

ZNA Cadix-Hematology

Antwerp, Belgium

Az St-Jan Brugge-Oostende A.V.

Bruges, Belgium

AOU Careggi (Department of Experimental and Clinical Medicine)

Florence, Italy

Azienda Ospedaliero - Universitaria Maggiore della Carità (SCDU Ematologia)

Novara, Italy

AO Ospedale di Circolo, PO Varese (Ematologia)

Varese, Italy

Amsterdam UMC location Vumc (Hematology)

Amsterdam, Netherlands

Cardiff and Vale University Health Board - University Hospital Wales (Hematology)

Cardiff, United Kingdom

Beatson West of Scotland Cancer Centre (Hematology)

Glasgow, United Kingdom

Guys and St Thomas' Hospital - Haematology

London, United Kingdom