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

Primary Purpose

Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pelabresib
Ruxolitinib
Placebo
Sponsored by
Constellation Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring Pelabresib, Ruxolitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥ 18 years
  • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
  • Adequate hematologic, renal, and hepatic function
  • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
  • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
  • Spleen volume of ≥ 450 cm^3
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Splenectomy or splenic irradiation in the previous 6 months
  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment
  • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm

Sites / Locations

  • University of Alabama at Birmingham
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • UC San Diego Moores Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • UCLA Medical Center
  • Yale University School of Medicine
  • Georgetown University
  • Mayo Clinic
  • University of Miami Hospital
  • Moffitt Cancer Center
  • Northwestern
  • University of Chicago Medical Center
  • Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
  • Loyola University - Cardinal Bernardin Cancer Center
  • Franciscan Health/Indiana blood and Marrow Transplantation
  • Norton Cancer Institute, St. Matthews Campus
  • University of Michigan Medical Center
  • Washington University
  • Cancer Care Specialists
  • Summit Medical Group - Cancer Center
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical College- New York Presbyterian Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Oregon Health and Science University
  • MD Anderson Cancer Center
  • Mays Cancer Center at UT Health San Antonio MD Anderson
  • Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
  • Sydney Adventist Hospital
  • Icon Cancer Centre
  • Royal Adelaide Hospital
  • Monash Health
  • Peninsula Private Hospital Clinical Trials Unit
  • USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
  • One Clinical Research PTY LTD
  • Calvary North Adelaide Hospital
  • LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
  • Krankenhaus der Elisabethinen Linz
  • ZNA
  • AZ Sint-Jan
  • Cliniques universitaires Saint-Luc
  • UZ Brussel
  • Hôpital de Jolimont
  • UZ Leuven
  • Domaine Universitaire du Sart Tilman
  • Tom Baker Cancer Centre
  • University of Alberta Hospital
  • London Health Sciences Center - Victoria Hospital
  • Princess Margaret Cancer Center
  • Jewish General Hospital
  • Hôpital Maisonneuve-Rosemont
  • The Ottawa Hospital General Campus
  • Fakultni nemocnice Hradec Kralove
  • University Hospital Olomouc
  • CHU Amiens Picardie
  • CHU Henri-Mondor
  • CHU Henri-Mondor
  • Centre Hospitalier
  • Hopital de la Conception
  • Hôpital l'Archet 1
  • CHU DE NIMES _Institut de Cancérologie du Gard
  • Centre d'Investigations Cliniques
  • Centre Hospitalier Lyon Sud Secteur 1G
  • Chu Pontchaillou - Service Hematologie
  • Institut de Cancérologie Lucien Neuwirth
  • Hôpital Bretonneau
  • Chru Brabois
  • Universitätsklinikum Ulm
  • Hämatologisch-Onkologische Praxis Augsburg
  • Johannes Wesling Klinikum Minden
  • Klinikum Chemnitz, Innere Medizin III
  • Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
  • Universitätsklinikum Jena, Klinik für Innere Medizin II
  • Universitätsklinikum Hamburg-Eppendorf (UKE), II. Medizinische Klinik und Poliklinik
  • University Hospital of Alexandroupolis
  • General Hospital, School of Medicine National and Kapodistrian University of Athens
  • Laiko General Hospital
  • Ηippokration General Hospital
  • Princess Margaret Hospital
  • Prince of Wales Hospital
  • : Pecs University, 1st Department of Medicine
  • Semmelweis University - Internal Medicine and Oncology Clinic
  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
  • Petz Aladar Egyetemi Oktato Korhaz
  • Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
  • Barzilai Medical Center
  • Soroka Medical Center
  • Shamir Medical Center
  • Rambam Health Corporation
  • Lady Davis Carmel Medical Center
  • Wolfson Medical Center
  • Wolfson Medical Center
  • Shaarei Zedek
  • Hadassah University Hospital-Ein Kerem
  • Shaarei Zedek
  • Rabin Medical Center - Beilinson Campus,
  • Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • A.O.U. Policlinico S. Orsola-Malpighi
  • AOU Policlinico G. Rodolico - San Marco
  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  • Azienda Ospedaliera Universitaria Careggi
  • Ospedale Policlinico San Martino IRCCS
  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera San Gerardo di Monza
  • AOU S.Luigi Gonzaga
  • Ospedale Sant'Eugenio
  • Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
  • National Cancer Center
  • Gyeongsang National University Hospital
  • Inje University Haeundae Paik Hospital
  • Pusan National University Hospital
  • Inje University Busan Paik Hospital
  • Kyungpook National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Hospital
  • Cha Bundang Medical Center Cha University
  • The Catholic University Of Korea St. Vincent Hospital
  • Gachon University Gil Medical Center
  • Jeonbuk National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Hanyang University Medical Center
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • The Catholic University of Korea
  • The Catholic University of South Korea Seoul St. Mary's Hospital
  • Ulsan University Hospital
  • Hospital Sultanah Aminah
  • Hospital Sultanah Bahiyah
  • Hospital Pulau Pinang
  • :Hospital Ampang
  • Sunway Medical Centre
  • University Malaya Medical Centre
  • Amsterdam UMC
  • Maastricht University Medical Center
  • Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
  • Uniwersyteckie Centrum Kliniczne
  • Pratia Onkologia Katowice
  • Centrum Medyczne Pratia
  • Nasz Lekarz Przychodnie Medyczne
  • Hospital Universitario Central de Asturias
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • Hospital Clinic de Barcelona
  • Vall d'Hebron Institute of Oncology
  • Hospital Universitario De Burgos
  • Hospital San Pedro de Alcantara
  • ICO Girona - Hospital Universitari de Girona
  • Hospital Universitario de Gran Canaria Dr. Negrin
  • Hospital Universitario Fundación Jiménez Díaz
  • Complejo Hospitalario de Navarra
  • Hospital Universitario de Salamanc
  • Hospital Virgen Macarena
  • Hospital Clínico Universitario de Valencia
  • Chang Gung Memorial Hospital Chiayi
  • China Medical University Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Songklanagarind Hospital
  • Chulabhorn Hospital
  • Srinagarind hospital,Khon Kaen University
  • King Chulalongkorn Memorial Hospital
  • Rajavithi Hospital
  • Ankara University Faculty of Medicine Cebeci Research and Application Hospital
  • Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
  • Antalya Medstar Hospital
  • Edirne Trakya University Faculty of Medicine Hospital
  • Gaziantep University Sahinbey Research and Application Center Hospital
  • Izmir Ege University Faculty of Medicine Hospital
  • Kocaeli University Application
  • Mersin University
  • Samsun 19 Mayıs University Health Application Research Hospital
  • Western General Hospital
  • University Hospital of Wales
  • Pilgrim Hospital
  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
  • Imperial College Healthcare NHS Trust, Hammersmith Hospital
  • University College London Hospitals
  • Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pelabresib + ruxolitinib

Placebo + ruxolitinib

Arm Description

Pelabresib monohydrate tablets + ruxolitinib phosphate tablets

Matching placebo tablets + ruxolitinib phosphate tablets

Outcomes

Primary Outcome Measures

Splenic response at Week 24
The primary endpoint of the study is splenic response, defined as a ≥35% reduction from baseline in spleen volume as measured by magnetic resonance imaging (MRI) or computerized tomography (CT), at Week 24.

Secondary Outcome Measures

Total Symptom Score response at Week 24
The key secondary endpoint of the study is Total Symptom Score response, defined as a ≥50% decrease from baseline in Total Symptom Score as measured by the Myelofibrosis Symptom Assessment Form v4.0, at Week 24. A higher Total Symptom Score indicates a higher disease burden and thus a worse outcome.

Full Information

First Posted
October 20, 2020
Last Updated
September 22, 2023
Sponsor
Constellation Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04603495
Brief Title
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Acronym
MANIFEST-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
August 24, 2023 (Actual)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Constellation Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Keywords
Pelabresib, Ruxolitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This study has a double-blind design in which patients and investigators are blinded to study drug; study drugs will be packaged identically. All patients will be randomly assigned to either treatment group in a 1:1 ratio. The blind should only be broken in the case of emergency.
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelabresib + ruxolitinib
Arm Type
Experimental
Arm Description
Pelabresib monohydrate tablets + ruxolitinib phosphate tablets
Arm Title
Placebo + ruxolitinib
Arm Type
Active Comparator
Arm Description
Matching placebo tablets + ruxolitinib phosphate tablets
Intervention Type
Drug
Intervention Name(s)
Pelabresib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Splenic response at Week 24
Description
The primary endpoint of the study is splenic response, defined as a ≥35% reduction from baseline in spleen volume as measured by magnetic resonance imaging (MRI) or computerized tomography (CT), at Week 24.
Time Frame
24 weeks of treatment
Secondary Outcome Measure Information:
Title
Total Symptom Score response at Week 24
Description
The key secondary endpoint of the study is Total Symptom Score response, defined as a ≥50% decrease from baseline in Total Symptom Score as measured by the Myelofibrosis Symptom Assessment Form v4.0, at Week 24. A higher Total Symptom Score indicates a higher disease burden and thus a worse outcome.
Time Frame
24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18 years Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia) Adequate hematologic, renal, and hepatic function Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0 Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system Spleen volume of ≥ 450 cm^3 Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: Splenectomy or splenic irradiation in the previous 6 months Chronic or active conditions and/or concomitant medication use that would prohibit treatment Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-5975
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Loyola University - Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Franciscan Health/Indiana blood and Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Norton Cancer Institute, St. Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cancer Care Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Summit Medical Group - Cancer Center
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College- New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mays Cancer Center at UT Health San Antonio MD Anderson
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Icon Cancer Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peninsula Private Hospital Clinical Trials Unit
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
City
Buderim
ZIP/Postal Code
QLD 4556
Country
Australia
Facility Name
One Clinical Research PTY LTD
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Calvary North Adelaide Hospital
City
North Adelaide
Country
Australia
Facility Name
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
ZNA
City
Antwerpen
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hôpital de Jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Domaine Universitaire du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
London Health Sciences Center - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
The Ottawa Hospital General Campus
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Henri-Mondor
City
Créteil
ZIP/Postal Code
94010 Cedex
Country
France
Facility Name
CHU Henri-Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hopital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital l'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU DE NIMES _Institut de Cancérologie du Gard
City
Nîmes
Country
France
Facility Name
Centre d'Investigations Cliniques
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud Secteur 1G
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Chu Pontchaillou - Service Hematologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Chru Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Hämatologisch-Onkologische Praxis Augsburg
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86151
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
Klinikum Chemnitz, Innere Medizin III
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
City
Halle
State/Province
Sachsen
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin II
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (UKE), II. Medizinische Klinik und Poliklinik
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupolis
Country
Greece
Facility Name
General Hospital, School of Medicine National and Kapodistrian University of Athens
City
Athens
Country
Greece
Facility Name
Laiko General Hospital
City
Athens
Country
Greece
Facility Name
Ηippokration General Hospital
City
Athens
Country
Greece
Facility Name
Princess Margaret Hospital
City
Hong Kong
State/Province
Kowloon
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
New Territories
Country
Hong Kong
Facility Name
: Pecs University, 1st Department of Medicine
City
Pécs
State/Province
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Semmelweis University - Internal Medicine and Oncology Clinic
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Egyetemi Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
City
Nyíregyháza
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
60930000
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
Itayz@wmc.gov.il
Country
Israel
Facility Name
Wolfson Medical Center
City
H̱olon
Country
Israel
Facility Name
Shaarei Zedek
City
Jerusalem
ZIP/Postal Code
9103102,
Country
Israel
Facility Name
Hadassah University Hospital-Ein Kerem
City
Jerusalem
ZIP/Postal Code
9590300
Country
Israel
Facility Name
Shaarei Zedek
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Campus,
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
A.O.U. Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
AOU Policlinico G. Rodolico - San Marco
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
City
Ferrara
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
Country
Italy
Facility Name
Ospedale Policlinico San Martino IRCCS
City
Genova
Country
Italy
Facility Name
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
City
Meldola
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza
Country
Italy
Facility Name
AOU S.Luigi Gonzaga
City
Orbassano
Country
Italy
Facility Name
Ospedale Sant'Eugenio
City
Rome
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
City
Varese
Country
Italy
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju-si
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Cha Bundang Medical Center Cha University
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic University Of Korea St. Vincent Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Jeonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08307
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of South Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
George Town
State/Province
Penang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
:Hospital Ampang
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Sunway Medical Centre
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47500
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
City
Biała Podlaska
ZIP/Postal Code
21-50
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-293
Country
Poland
Facility Name
Pratia Onkologia Katowice
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne Pratia
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Vall d'Hebron Institute of Oncology
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario De Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
ICO Girona - Hospital Universitari de Girona
City
Girona
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Salamanc
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Chang Gung Memorial Hospital Chiayi
City
Chiayi City
Country
Taiwan
Facility Name
China Medical University Hospital
City
Chiayi City
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Songklanagarind Hospital
City
Songkla
State/Province
Hat Yai District
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Chulabhorn Hospital
City
Bangkok
State/Province
Lak Si
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Srinagarind hospital,Khon Kaen University
City
Khon Kaen
State/Province
Mueang Khon Kaen District
ZIP/Postal Code
40002
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rajavithi Hospital
City
Bangkok
State/Province
Ratchathewi District
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ankara University Faculty of Medicine Cebeci Research and Application Hospital
City
Ankara
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
City
Ankara
Country
Turkey
Facility Name
Antalya Medstar Hospital
City
Antalya
Country
Turkey
Facility Name
Edirne Trakya University Faculty of Medicine Hospital
City
Edirne
Country
Turkey
Facility Name
Gaziantep University Sahinbey Research and Application Center Hospital
City
Gaziantep
Country
Turkey
Facility Name
Izmir Ege University Faculty of Medicine Hospital
City
İzmir
Country
Turkey
Facility Name
Kocaeli University Application
City
Kocaeli
Country
Turkey
Facility Name
Mersin University
City
Mersin
Country
Turkey
Facility Name
Samsun 19 Mayıs University Health Application Research Hospital
City
Samsun
Country
Turkey
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Pilgrim Hospital
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust, Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36164005
Citation
Mascarenhas J, Kremyanskaya M, Patriarca A, Harrison C, Bose P, Rampal RK, Palandri F, Devos T, Passamonti F, Hobbs G, Talpaz M, Vannucchi A, Kiladjian JJ, Verstovsek S, Hoffman R, Salama ME, Chen D, Taverna P, Chang A, Colak G, Klein S, Gupta V. MPN-375 BET Inhibitor Pelabresib (CPI-0610) Combined With Ruxolitinib in Patients With Myelofibrosis - JAK Inhibitor-Naie or With Suboptimal Response to Ruxolitinib - Preliminary Data From the MANIFEST Study. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S335-S336. doi: 10.1016/S2152-2650(22)01456-2.
Results Reference
derived
PubMed Identifier
35950489
Citation
Harrison CN, Gupta VK, Gerds AT, Rampal R, Verstovsek S, Talpaz M, Kiladjian JJ, Mesa R, Kuykendall AT, Vannucchi AM, Palandri F, Grosicki S, Devos T, Jourdan E, Wondergem MJ, Al-Ali HK, Buxhofer-Ausch V, Alvarez-Larran A, Patriarca A, Kremyanskaya M, Mead AJ, Akhani S, Sheikine Y, Colak G, Mascarenhas J. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis. Future Oncol. 2022 Sep;18(27):2987-2997. doi: 10.2217/fon-2022-0484. Epub 2022 Aug 11.
Results Reference
derived

Learn more about this trial

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

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