Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Myelofibrosis (MF) Clinical Trial

— TRANSFORM-2  

Official title:

A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04468984
• Other study ID #: M20-178
• Secondary ID: 2020-000557-27
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 31, 2020
• Est. completion date: January 29, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF.

Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world.

In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: January 29, 2025
• Est. primary completion date: November 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.

-- Has at least 2 symptoms each with an average score >= 3 or an average total score of >= 12, as measured by the MFSAF v4.0.

• Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.

• Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).

• Must currently be on treatment or have received prior treatment with a single Janus Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in addition to the minimum splenomegaly and symptom burden also required for eligibility):

• Treatment with ruxolitinib for >= 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.

• Treatment with ruxolitinib for < 24 weeks with documented disease progression while on therapy as defined by any of the following:

• Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.

• A >= 100% increase in the palpable distance below the LCM in participants with measurable spleen distance 5 to 10 centimeters (cm) prior to the initiation of ruxolitinib.

• A >= 50% increase in the palpable distance below the LCM in participants with measurable spleen distance > 10 cm prior to the initiation of ruxolitinib.

• A spleen volume increase of >= 25% (as assessed by Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan) in participants with a spleen volume assessment prior to the initiation of ruxolitinib.

• Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for >= 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of >= 30 mg but unable to reduce dose further due to lack of efficacy.

Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated = Grade 3 toxicity.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Splenomegaly defined as palpable spleen measurement >= 5 cm below left costal margin or spleen volume >= 450 cm3 as assessed centrally by MRI or CT scan.

• Baseline platelet count >= 100 × 10^9/L.

Exclusion Criteria:

• Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, or prior use of > 1 JAK2 inhibitor or stem cell transplant.

• Eligible for stem cell transplantation at the time of study entry.

• Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).

• Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).

Related Conditions & MeSH terms

• Myelofibrosis (MF)
• Primary Myelofibrosis

Intervention

Drug:
• Navitoclax
Tablet; Oral
• Ruxolitinib
Tablet; Oral
• Best Available Therapy (BAT)
Tablet/Capsule; Oral or Solution for Subcutaneous Injection

Locations

Country	Name	City	State
Australia	The Kinghorn Cancer Centre /ID# 221097	Darlinghurst	New South Wales
Australia	Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 223848	East Albury	New South Wales
Australia	The Alfred Hospital /ID# 221096	Melbourne	Victoria
Australia	Royal Perth Hospital /ID# 221099	Perth	Western Australia
Australia	Calvary Mater Newcastle /ID# 224324	Waratah	New South Wales
Austria	Medizinische Universitaet Graz /ID# 220919	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 220914	Linz	Oberoesterreich
Austria	Universitaetsklinikum St. Poelten /ID# 221709	Sankt Poelten	Niederoesterreich
Austria	Medizinische Universitaet Wien /ID# 220911	Vienna	Wien
Austria	Klinikum Wels-Grieskirchen GmbH /ID# 220915	Wels	Oberoesterreich
Austria	Hanusch Krankenhaus /ID# 220912	Wien
Belgium	ZNA Cadix /ID# 221468	Antwerp	Antwerpen
Belgium	Grand Hopital de Charleroi /ID# 224827	Charleroi	Hainaut
Belgium	UZ Gent /ID# 220841	Gent	Oost-Vlaanderen
Belgium	AZ-Delta /ID# 221469	Roeselare	West-Vlaanderen
Belgium	Vitaz /Id# 228150	Sint-Niklaas
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 224221	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 231650	Pleven
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 231651	Sofia
Bulgaria	UMHAT Alexandrovska EAD /ID# 231652	Sofiya	Sofia
Bulgaria	UMHAT Sveta Marina /ID# 234119	Varna
Canada	Juravinski Cancer Centre /ID# 220887	Hamilton	Ontario
Canada	CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433	Levis	Quebec
Canada	McGill University Health Center Research Institute /ID# 222614	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 238858	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre /ID# 253942	Toronto	Ontario
Croatia	Klinicki bolnicki centar Osijek /ID# 231503	Osijek
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 230800	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 230801	Zagreb	Grad Zagreb
Croatia	Klinicka bolnica Merkur /ID# 230799	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 230798	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Brno /ID# 220959	Brno
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 220969	Praha
Denmark	Aalborg University Hospital /ID# 224391	Aalborg	Nordjylland
Denmark	Roskilde Sygehus /ID# 224456	Roskilde	Sjælland
France	Chu Angers /Id# 219129	Angers
France	Hopital Avicenne - APHP /ID# 221287	Bobigny	Ile-de-France
France	Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 223771	Chambery CEDEX	Savoie
France	CHU de Nantes, Hotel Dieu -HME /ID# 219127	Nantes	Pays-de-la-Loire
France	Chu de Nice-Hopital Larchet Ii /Id# 256291	Nice	Alpes-Maritimes
France	CHU NIMES - Hopital Caremeau /ID# 219128	Nimes CEDEX 9	Gard
France	AP-HP - Hopital Saint-Louis /ID# 221390	Paris
France	Centre Hospitalier Universitaire de Bordeaux /ID# 222696	Pessac CEDEX	Gironde
France	HCL - Hopital Lyon Sud /ID# 222695	Pierre Benite CEDEX	Rhone
Germany	Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025	Augsburg	Bayern
Germany	Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695	Bochum
Germany	Klinikum Chemnitz gGmbH /ID# 224575	Chemnitz
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346	Dresden	Sachsen
Germany	OncoResearch Lerchenfeld GmbH /ID# 225034	Hamburg
Germany	Universitatsklinikum Mannheim /ID# 221529	Mannheim	Baden-Wuerttemberg
Germany	Klinikum rechts der Isar /ID# 221526	Munich
Germany	Stauferklinikum Schwaebisch Gmuend /ID# 223948	Mutlangen	Baden-Wuerttemberg
Germany	Universitaetsmedizin Rostock /ID# 224157	Rostock	Mecklenburg-Vorpommern
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179	Athens
Greece	General Hospital of Athens Laiko /ID# 221175	Athens	Attiki
Greece	Olympion General Clinic /ID# 261423	Patras	Achaia
Greece	University General Hospital of Patras /ID# 221178	RION Patras Achaia
Greece	General Hospital of Thessaloniki George Papanikolaou /ID# 221463	Thessaloniki
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 220947	Debrecen	Hajdu-Bihar
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948	Kaposvár	Somogy
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946	Nyiregyhaza	Szabolcs-Szatmar-Bereg
Hungary	Szegedi Tudományegyetem /ID# 220955	Szeged
Hungary	Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949	Szekesfehervar	Fejer
Israel	HaEmek Medical Center /ID# 220839	Afula	H_efa
Israel	Assuta Ashdod Medical Center /ID# 225281	Ashdod	HaDarom
Israel	Rabin Medical Center /ID# 219139	Haifa
Israel	Rambam Health Care Campus /ID# 219121	Haifa	H_efa
Israel	The Lady Davis Carmel Medical Center /ID# 222973	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 219111	Jerusalem	Yerushalayim
Israel	Hadassah Mt. Scopus /ID# 253394	Jerusalem	Yerushalayim
Israel	Galilee Medical Center /ID# 225280	Nahariya	HaTsafon
Israel	The Chaim Sheba Medical Center /ID# 219136	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 219135	Tel Aviv	Tel-Aviv
Israel	Yitzhak Shamir Medical Center /ID# 222972	Zerifin	HaMerkaz
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222	Bergamo
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077	Bologna
Italy	Presidio Ospedaliero Gaspare Rodolico /ID# 219089	Catania
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 219090	Florence
Italy	ASST Monza/Ospedale San Gerardo /ID# 225113	Monza	Monza E Brianza
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 224673	Napoli
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078	Palermo
Italy	Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220	Reggio Calabria
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 219087	Rome	Lazio
Italy	Sapienza University /ID# 225731	Rome	Roma
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 238438	Torette	Ancona
Italy	AOU Citta della Salute e della Scienza di Torino /ID# 221223	Torino	Piemonte
Italy	Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241	Udine
Italy	ASST Sette Laghi /ID# 234183	Varese
Italy	Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079	Vicenza
Japan	Aomori Prefectural Central Hospital /ID# 221778	Aomori-shi	Aomori
Japan	Juntendo University Hospital /ID# 221154	Bunkyo-ku	Tokyo
Japan	Nippon Medical School Hospital /ID# 221676	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 224546	Chiba-shi	Chiba
Japan	University of Yamanashi Hospital /ID# 221706	Chuo-shi	Yamanashi
Japan	Kyushu University Hospital /ID# 221606	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 221877	Fukushima-shi	Fukushima
Japan	Gifu University Hospital /ID# 224371	Gifu-shi	Gifu
Japan	Kansai Medical University Hospital /ID# 257289	Hirakata-shi	Osaka
Japan	Juntendo University Shizuoka Hospital /ID# 221780	Izunokuni-shi	Shizuoka
Japan	Shonan Kamakura General Hospital /ID# 223030	Kamakura-shi	Kanagawa
Japan	Kanazawa University Hospital /ID# 223028	Kanazawa-shi	Ishikawa
Japan	National Cancer Center Hospital East /ID# 226653	Kashiwa-shi	Chiba
Japan	Kobe City Medical Center General Hospital /ID# 221156	Kobe-shi	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center /ID# 222334	Koshigaya	Saitama
Japan	Kumamoto Shinto General Hospital /ID# 255645	Kumamoto-shi	Kumamoto
Japan	Kurashiki Central Hospital /ID# 221690	Kurashiki-shi	Okayama
Japan	Kyoto University Hospital /ID# 223008	Kyoto-shi	Kyoto
Japan	University of Miyazaki Hospital /ID# 221821	Miyazaki-shi	Miyazaki
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150	Nagoya-shi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 223034	Niigata-shi	Niigata
Japan	Sapporo Hokuyu Hospital /ID# 221149	Sapporo-shi	Hokkaido
Japan	Tokyo Medical University Hospital /ID# 221540	Shinjuku-ku	Tokyo
Japan	Iwate Medical University Hospital /ID# 222044	Shiwa-gun	Iwate
Japan	Osaka University Hospital /ID# 221159	Suita-shi	Osaka
Japan	Tokyo Metropolitan Bokutoh Hospital /ID# 254774	Sumida-ku	Tokyo
Japan	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 257944	Tokyo
Japan	Ehime University Hospital /ID# 221158	Toon-shi	Ehime
Japan	Fujita Health University Hospital /ID# 221598	Toyoake	Aichi
Japan	Mie University Hospital /ID# 221665	Tsu-shi	Mie
Korea, Republic of	Pusan National University Hospital /ID# 220980	Busan
Korea, Republic of	Gachon University Gil Medical Center /ID# 220972	Incheon	Gyeonggido
Korea, Republic of	Samsung Medical Center /ID# 221091	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 219060	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219061	Seoul	Seoul Teugbyeolsi
New Zealand	Aotearoa Clinical Trials /ID# 232201	Papatoetoe	Auckland
Poland	Uniwersyteckie Centrum Kliniczne /ID# 221298	Gdansk	Pomorskie
Poland	Pratia Onkologia Katowice /ID# 224526	Katowice
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160	Krakow	Malopolskie
Poland	Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161	Lodz	Lodzkie
Poland	Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221124	Lublin	Lubelskie
Poland	ARS-MEDICAL Sp. z o.o. /ID# 238336	Pila	Wielkopolskie
Poland	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031	Poznan	Wielkopolskie
Poland	Lux Med Onkologia - Szpital Szamocka /Id# 221265	Warszawa	Mazowieckie
Poland	MTZ Clinical Research Powered by Pratia /ID# 221759	Warszawa	Mazowieckie
Puerto Rico	Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281	San Juan
Russian Federation	Hospital n.a. V.V. Veresaev /ID# 225221	Moscow
Russian Federation	Moscow State budget healthcare /ID# 221116	Moscow	Moskva
Russian Federation	Almazov National Medical Research Centre /ID# 221114	Sankt-Peterburg
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115	Sankt-Peterburg
Russian Federation	Tula Regional Clinical Hospital /ID# 221302	Tula
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 231059	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 231058	Belgrade	Beograd
Serbia	University Clinical Center Vojvodina /ID# 231057	Novi Sad
South Africa	Duplicate_Wits Clinical Research Site /ID# 231554	Johannesburg	Gauteng
South Africa	Alberts Cellular Therapy /ID# 231556	Pretoria	Gauteng
Spain	Complejo Hospitalario Universitario A Coruña /ID# 224617	A Coruña	A Coruna
Spain	Hospital Universitario Germans Trias i Pujol /ID# 233727	Badalona	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 220922	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 240979	Barcelona
Spain	Hospital Universitario Virgen de las Nieves /ID# 253936	Granada
Spain	Hospital Universitario Dr. Negrin /ID# 220923	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario 12 de Octubre /ID# 233726	Madrid
Spain	Hospital Universitario La Paz /ID# 224813	Madrid
Spain	Hospital Regional Universitario de Malaga /ID# 221906	Malaga
Spain	Hospital Universitario Central de Asturias /ID# 224815	Oviedo	Asturias
Spain	Hospital Universitario de Salamanca /ID# 221904	Salamanca
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 221616	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen del Rocio /ID# 221932	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 220920	Valencia
Sweden	Skane University Hospital Lund /ID# 220834	Lund	Skane Lan
Switzerland	Duplicate_Universitätsspital Basel /ID# 221261	Basel	Basel-Stadt
Switzerland	Inselspital, Universitaetsspital Bern /ID# 223439	Bern
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 218985	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 218979	Taichung
Taiwan	Chi Mei Hospital - Liouying /ID# 221144	Tainan City
Taiwan	Taipei Veterans General Hosp /ID# 221147	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 218982	Taoyuan City
Turkey	Gulhane Askeri Tip Academy /ID# 224568	Ankara
Turkey	Trakya University Medical Facu /ID# 224572	Edirne, Istanbul
Turkey	Ege University Medical Faculty /ID# 224570	Izmir
Turkey	Mersin University Medical /ID# 224571	Mersin
Turkey	Ondokuz mayis University Facul /ID# 224567	Samsun
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 221334	Birmingham
United Kingdom	NHS Lothian /ID# 224378	Edinburgh
United Kingdom	James Paget University Hospitals NHS Foundation Trust /ID# 221219	Great Yarmouth	Norfolk
United Kingdom	United Lincolnshire Hospitals NHS Trust /ID# 224613	Lincoln	Lincolnshire
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 221041	London	London, City Of
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335	Newcastle upon Tyne
United States	University of Michigan /ID# 218463	Ann Arbor	Michigan
United States	Augusta University Georgia Cancer Center /ID# 219051	Augusta	Georgia
United States	American Oncology Partners of Maryland /ID# 222836	Bethesda	Maryland
United States	Dana-Farber Cancer Institute /ID# 218998	Boston	Massachusetts
United States	Ironwood Cancer & Res Ctr /ID# 222162	Chandler	Arizona
United States	MetroHealth Medical Center /ID# 222650	Cleveland	Ohio
United States	Columbus Regional Research Institute /ID# 224410	Columbus	Georgia
United States	Henry Ford Health System /ID# 221190	Detroit	Michigan
United States	Northwest Oncology & Hematology - Elk Grove Village /ID# 222818	Elk Grove Village	Illinois
United States	Providence Everett /ID# 223130	Everett	Washington
United States	Virginia Cancer Specialists - Fairfax /ID# 223016	Fairfax	Virginia
United States	Summit Medical Group-Florham Park /ID# 222620	Florham Park	New Jersey
United States	St. Mary's Hospital Regional Cancer Center /ID# 224229	Grand Junction	Colorado
United States	HSHS St. Vincent Hospital /ID# 224468	Green Bay	Wisconsin
United States	The Cancer Institute at St. Francis Hospital /ID# 231782	Greenvale	New York
United States	Hackensack Univ Med Ctr /ID# 219047	Hackensack	New Jersey
United States	Duplicate_Houston Methodist Hospital /ID# 223103	Houston	Texas
United States	Indiana Blood & Marrow Transpl /ID# 221587	Indianapolis	Indiana
United States	Moores Cancer Center at UC San Diego /ID# 219009	La Jolla	California
United States	Long Beach Memorial Medical Ct /ID# 224542	Long Beach	California
United States	Loyola University Medical Ctr /ID# 219048	Maywood	Illinois
United States	Ochsner Clinic Foundation-New Orleans /ID# 222777	New Orleans	Louisiana
United States	Tulane Medical Center - New Orleans /ID# 222940	New Orleans	Louisiana
United States	Manhattan Hematology Oncology MHO Associates /ID# 223193	New York	New York
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081	New York	New York
United States	Fox Chase Cancer Center /ID# 223955	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania /ID# 219001	Philadelphia	Pennsylvania
United States	William Beaumont Hospital /ID# 222705	Royal Oak	Michigan
United States	Saint Louis University Cancer Center /ID# 222287	Saint Louis	Missouri
United States	Utah Cancer Specialists Salt Lake Clinic /ID# 221962	Salt Lake City	Utah
United States	University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942	San Antonio	Texas
United States	Highlands Oncology Group, PA /ID# 221826	Springdale	Arkansas
United States	Icri /Id# 221967	Whittier	California
United States	Atrium Health Wake Forest Baptist Medical Center /ID# 222899	Winston-Salem	North Carolina
United States	Yakima Valley Memorial Hosp /ID# 224368	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)	Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.	At Week 24
Secondary	Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)	Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.	Baseline (Week 0) Up to Week 24
Secondary	Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time	Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.	Baseline (Week 0) Up to Week 97
Secondary	Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis	Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.	Baseline (Week 0) Up to Week 97
Secondary	Percentage of Participants with Anemia Response	Anemia response per International Working Group (IWG) criteria will be assessed.	Baseline (Week 0) Up to Week 97
Secondary	Percentage of Participants with Overall Survival	Overall survival is defined as the time from start of study to the date of death from any cause.	Last Visit Up to 5 Years
Secondary	Percentage of Participants with Leukemia-free Survival	Leukemia free survival is the time from start of study to the date of development of leukemia.	Last Visit Up to 5 Years
Secondary	Percentage of Participants with Change in Fatigue	Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.	Baseline (Week 0) Up to Week 24
Secondary	Time to Deterioration of Physical Functioning	Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.	Baseline (Week 0) Up to Week 97
Secondary	Percentage of Participants with at Least 50% Reduction in TSS	At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.	Baseline (Week 0) Up to Week 97