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ACTIVE NOT RECRUITING
NCT04603495
PHASE3

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Official title: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2021-04-09

Completion Date

2027-06-30

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Pelabresib

Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days). Pelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF.

DRUG

Ruxolitinib

Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.

DRUG

Placebo

Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib.

Locations (156)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Chandler, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL

Decatur, Illinois, United States

Franciscan Health/Indiana blood and Marrow Transplantation

Indianapolis, Indiana, United States

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Washington University

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College- New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center - San Antonio

San Antonio, Texas, United States

Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute

Seattle, Washington, United States

Icon Cancer Centre

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peninsula Private Hospital Clinical Trials Unit

Frankston, Victoria, Australia

USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic

Buderim, Australia

One Clinical Research PTY LTD

Nedlands, Australia

LKH - Universitätsklinikum Graz; Abteilung für Hämatologie

Graz, Austria

Krankenhaus der Elisabethinen Linz

Linz, Austria

Kepler University Hospital

Linz, Austria

University Hospital Salzburg

Salzburg, Austria

ZNA

Antwerp, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Hôpital de Jolimont

La Louvière, Belgium

UZ Leuven

Leuven, Belgium

Domaine Universitaire du Sart Tilman

Liège, Belgium

Tom Baker Cancer Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

London Health Sciences Center - Victoria Hospital

London, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

University Hospital Olomouc

Olomouc, Czechia

Amiens South Hospital univerisy - Hopital Sud

Amiens, France

Centre Hospitalier

Le Mans, France

Hôpital l'Archet 1

Nice, France

Gard Cancer Institute

Nîmes, France

Centre Hospitalier Lyon Sud Secteur 1G

Pierre-Bénite, France

Chu Pontchaillou - Service Hematologie

Rennes, France

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Hôpital Bretonneau

Tours, France

Chru Brabois

Vandœuvre-lès-Nancy, France

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Hämatologisch-Onkologische Praxis Augsburg

Augsburg, Bavaria, Germany

Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)

Halle, Saxony, Germany

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, Thuringia, Germany

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Laiko General Hospital

Athens, Greece

UGH of Ioannina

Ioannina, Greece

University General Hospital of Patras

Rio, Greece

Princess Margaret Hospital

Hong Kong, Kowloon, Hong Kong

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong

: Pecs University, 1st Department of Medicine

Pécs, Pecs, Hungary

Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia

Nyíregyháza, Hungary

Soroka Medical Center

Beersheba, Israel

Shamir Medical Center

Be’er Ya‘aqov, Israel

Rambam Health Corporation

Haifa, Israel

Lady Davis Carmel Medical Center

Haifa, Israel

Wolfson Medical Center

Holon, Israel

Hadassah University Hospital-Ein Kerem

Jerusalem, Israel

Shaarei Zedek

Nahariya, Israel

Rabin Medical Center - Beilinson Campus,

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy

A.O.U. Policlinico S. Orsola-Malpighi

Bologna, Italy

Regional Hospital Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Ferrara, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy

University Hospital Maggiore della Carità

Novara, Italy

AOU S.Luigi Gonzaga

Orbassano, Italy

University Hospital of Padova

Padova, Italy

University Hospital 'Paolo Giaccone' Polyclinic

Palermo, Italy

Ospedale Sant'Eugenio

Rome, Italy

Hospital Ordine Mauriziano of Turin

Turin, Italy

Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi

Varese, Italy

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

:Hospital Ampang

Ampang, Selangor, Malaysia

Sunway Medical Centre

Petaling Jaya, Selangor, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

Amsterdam UMC

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej

Biała Podlaska, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Pratia Onkologia Katowice

Katowice, Poland

Centrum Medyczne Pratia

Skorzewo, Poland

Nasz Lekarz Przychodnie Medyczne

Torun, Poland

And 56 more locations on ClinicalTrials.gov