Clinical trial NCT04173494: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
Official title: A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Keywords: Myelofibrosis
JAK inhibitor
Danazol
Momelotinib
Functional Iron deficiency
Activin receptor type 1
Anemia
Transfusion
Hepcidin
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Lead sponsor: Sierra Oncology LLC - a GSK company
Sponsor class: INDUSTRY
First posted: 2019-11-22
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).

Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.

Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.

Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.

Detailed description: MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years.
* Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).
* Symptomatic, defined as a TSS of \>= 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Baseline period (Day BL1).
* Anemic, defined as a Hgb \< 10 g/dL in Screening/Baseline period.
* Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for \>= 90 days, or \>= 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of \>= 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.
* Baseline splenomegaly, defined as having a palpable spleen at \>= 5 centimeter (cm), below the left costal margin, or with volume \>= 450 cubic centimeter (cm\^3) on imaging (ultrasound, magnetic resonance imaging \[MRI\] or computed tomography \[CT\] are acceptable), assessed during Screening at any point prior to Randomization.
* High risk, intermediate-2, or intermediate-1 risk MF as defined by Dynamic International Prognostic Scoring System (DIPSS), or DIPSS-plus.
* No allogeneic stem cell transplant planned.
* Acceptable laboratory assessments:

  1. Absolute neutrophil count (ANC) \>= 0.75 × 10\^9/Liter (L).
  2. Platelet count (PLT) \>= 25 × 10\^9/L (without requirement for platelet transfusion).
  3. Peripheral blast count \< 10%.
  4. Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) \<= 3 × Upper Limit Normal (ULN) (\<= 5 × ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days).
  5. Calculated creatinine clearance (CCr) \>= 30 milliliter per minute (mL/min) according to Cockcroft-Gault.
  6. Direct bilirubin \<= 2.0 × ULN.

Exclusion Criteria:

* Use of the following treatments within the time periods noted:

  1. Prior momelotinib treatment at any time.
  2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week prior to the first day of Baseline.
  3. Active anti-MF therapy within 1 week prior to the first day of Baseline.
  4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization.
  5. Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization.
  6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.
  7. Danazol within 3 months prior to Randomization.
  8. Splenic irradiation within 3 months prior to Randomization.
  9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.
* History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured.
* Prostate specific antigen (PSA) \> 4 nanograms per milliliter (ng/mL).
* Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI scan or CT scan for spleen volume measurement per protocol requirements.
* Any of the following (criteria a - k):

  1. Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial).
  2. Significant active or chronic bleeding event \>= Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.
  3. Unstable angina pectoris within 6 months prior to Randomization.
  4. Symptomatic congestive heart failure within 6 months prior to Randomization.
  5. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.
  6. QT Interval Corrected Using Fridericia's Formula (QTcF) interval \> 500 millisecond (msec), unless attributed to bundle branch block.
  7. Current progressive thrombosis despite treatment.
  8. History of porphyria.
  9. Child-Pugh score \>= 10.
  10. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor.
  11. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment.
* Participants with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen.
* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia.
* Known positive status for human immunodeficiency viruses (HIV).
* Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C).
* Unresolved non-hematologic toxicities from prior therapies that are \> Grade 1 per CTCAE v5.0.
* Presence of peripheral neuropathy \>= Grade 2 per CTCAE v5.0.
* Women who are already pregnant or lactating. Additional inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Total Symptom Score (TSS) Response Rate at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percentage of Participants With Transfusion Independence (TI) at Week 24
timeFrame: Week 24
measure: Splenic Response Rate (SRR) of >=25% at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in MFSAF TSS at Week 24
timeFrame: Baseline and Week 24
measure: Splenic Response Rate (SRR) of >= 35% at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks
timeFrame: Up to 24 weeks
measure: Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks
timeFrame: Up to 24 weeks
measure: Duration of MFSAF TSS Response
timeFrame: Up to a maximum of 151 weeks
measure: Duration of TI Response
timeFrame: Up to a maximum of 151 weeks
measure: Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks
timeFrame: Up to Week 24
measure: Percentage of Participants With Transfusion Dependence (TD) Status at Week 24
timeFrame: Week 24
measure: Percentage of Participants With a Hemoglobin Response
timeFrame: Baseline and Week 24
measure: Number of Baseline TD Participants With TI Status at Week 24
timeFrame: Week 24
measure: Duration of TI in Baseline TD Participants
timeFrame: Up to a maximum of 151 weeks
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24
timeFrame: Up to Week 24
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks
timeFrame: From Week 24 to a maximum of 151 weeks
measure: Overall Survival (OS)
timeFrame: Up to a maximum of 151 weeks
measure: Leukemia-free Survival (LFS)
timeFrame: Up to a maximum of 151 weeks
measure: Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital - Phoenix
state: Arizona
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
city: Whittier
country: United States
facility: American Institute of Research - Whittier
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital Anschutz Cancer Pavilion
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Rolling Meadows
country: United States
facility: Northwest Oncology & Hematology - Rolling Meadows
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine in Saint Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center - Presbyterian Hospital
state: New York
city: Avon
country: United States
facility: Cleveland Clinic - Richard E. Jacobs Health Center
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Garran
country: Australia
facility: Canberra Region Cancer Centre
state: Australian Capital Territory
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Perth Radiological Clinic - Magnetic Resonance Centre
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tyrol
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
state: Upper Austria
city: Wien
country: Austria
facility: Medizinische Universität Wien
state: Vienna
city: Steyr
country: Austria
facility: Oberösterreichische Gesundheitsholding GmbH
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
state: Brussels
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Notre Dame
state: Hainaut
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
city: Sofia
country: Bulgaria
facility: University Hospital St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Aleksandrovska
city: Sofia
country: Bulgaria
facility: National Specialized Hospital for Active Treatment of Haematologic Diseases
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre - Halifax Infirmary
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Hôpital de l'Enfant-Jésus
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
state: Jihormoravsky Kraj
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital - Syd
state: Nordjylland
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital - Roskilde
state: Sjælland
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Syddanmark
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
state: Aquitaine
city: Caen
country: France
facility: Hospital Center University Of Caen Normandie
state: Basse-Normandie
city: Lille
country: France
facility: Hôpital Claude Huriez
state: Hauts-de-France
city: Paris
country: France
facility: Hôpital Saint-Louis
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Saint-Antoine
state: Ile-de-France
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Limoges
state: Limousin
city: Lens
country: France
facility: Centre Hospitalier De Lens
state: Nord Pas-Des-Calais
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
state: Pays De La Loire
city: Amiens
country: France
facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
state: Picardie
city: Nice
country: France
facility: Hôpital l'Archet
state: Provence-Alpes-Côte d'Azur
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
state: Rhone-Alps
city: Angers
country: France
facility: Centre Hosptitalier Universitaire Angers
city: Lille
country: France
facility: Hôpital Saint-Vincent De Paul - Lille
city: Marseille
country: France
facility: Hôpital De La Conception
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thuringen
city: Köln
country: Germany
facility: Uniklinik Köln
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
city: Mutlangen
country: Germany
facility: Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdu-Bihar
city: Tatabánya
country: Hungary
facility: Szent Borbála Kórház
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely
state: Pest
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
state: Szabolcs-Szatmár-Bereg
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház Szombathely
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Be'er Ya'aqov
country: Israel
facility: Yitzhak Shamir Medical Center
state: Central District
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
state: Haifa District
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
state: Jerusalem District
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital-Nahariya
city: Petah tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
state: Florence
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Forli-Cesena
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo
state: Monza E Brianza
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
state: Pesaro E Urbino
city: Rionero In Vulture
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata
state: Potenza
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
state: Turin
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
state: Turin
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
city: Roma
country: Italy
facility: Umberto I - Policlinico di Roma
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi Borgo Roma
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu Gwang'yeogsi
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials
city: Wrocław
country: Poland
facility: Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
state: Lubelskie
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
state: Mazowieckie
city: Warszawa
country: Poland
facility: Alvamed Zakład Specjalistycznej Opieki Zdrowotnej
state: Mazowieckie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
state: Małopolskie
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu
state: Opolskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne w Gdańsku
state: Pomorskie
city: Chorzów
country: Poland
facility: Silesian Healthy Blood Clinic
state: Salskie
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
city: Craiova
country: Romania
facility: Spitalul Filantropia - Craiova
state: Dolj
city: Iaşi
country: Romania
facility: Institutul Regional De Oncologie Iasi
state: Iasi County
city: Târgu-Mureş
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Târgu Mureș
state: Mureș
city: Braşov
country: Romania
facility: Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov
city: Bucharest
country: Romania
facility: Coltea - Spital Clinic
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Girona
country: Spain
facility: Institut Català d'Oncologia Girona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragoza
country: Spain
facility: Hospital de Día Quirónsalud Zaragoza
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
state: Stockholm
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Västra Götalands Län
city: Uddevalla
country: Sweden
facility: Uddevalla Sjukhus
city: Puzi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
state: Chaiyi
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taichung
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Boston
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: England
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Guy's and Saint Thomas' NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: England
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: England
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire
state: Scotland
Study officials:
affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center
name: Srdan Verstovsek, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Health San Antonio Cancer Center, San Antonio, TX, USA
name: Ruben Mesa
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerds A, Verstovsek S, Vannucchi A, Al-Ali HK, Lavie D, Kuykendall A, Grosicki S, Iurlo A, Goh YT, Lazaroiu M, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Donahue R, Kawashima J, Mesa R. MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S340. doi: 10.1016/S2152-2650(22)01464-1.