Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

Myelofibrosis (MF) Clinical Trial

— TRANSFORM-1  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04472598
• Other study ID #: M16-191
• Secondary ID: 2020-000097-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 29, 2020
• Est. completion date: October 19, 2032

Study information

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

Clinical Trial Summary

Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: October 19, 2032
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) .
• Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization. -- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.
• Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
• Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
• Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

• Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
• Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
• 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 milligram daily) and low molecular weight heparin (LMWH).

Related Conditions & MeSH terms

• Myelofibrosis (MF)
• Primary Myelofibrosis

Intervention

Drug:
• Navitoclax
Tablet; Oral
• Ruxolitinib
Tablet; Oral
• Placebo for Navitoclax
Tablet; Oral

Locations

Country	Name	City	State
Australia	The Kinghorn Cancer Centre /ID# 221503	Darlinghurst	New South Wales
Australia	Townsville University Hospital /ID# 229794	Douglas	Queensland
Australia	Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311	East Albury	New South Wales
Australia	Gosford Hospital /ID# 221499	Gosford	New South Wales
Australia	Liverpool Hospital /ID# 221803	Liverpool	New South Wales
Australia	Alfred Health /ID# 221501	Melbourne	Victoria
Australia	Peter MacCallum Cancer Ctr /ID# 229795	Melbourne	Victoria
Australia	Royal Perth Hospital /ID# 223203	Perth	Western Australia
Austria	Medizinische Universitaet Graz /ID# 220910	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 220813	Linz	Oberoesterreich
Austria	Medizinische Universitaet Wien /ID# 220906	Vienna	Wien
Austria	Klinikum Wels-Grieskirchen GmbH /ID# 220901	Wels	Oberoesterreich
Austria	Hanusch Krankenhaus /ID# 220909	Wien
Belgium	ZNA Stuivenberg /ID# 221465	Antwerp
Belgium	AZ Sint-Jan Brugge /ID# 218805	Brugge
Belgium	UZ Gent /ID# 221125	Gent	Oost-Vlaanderen
Belgium	CHU UCL Namur - site Godinne /ID# 221127	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 218806	Leuven	Vlaams-Brabant
Belgium	Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874	Liege
Belgium	AZ-Delta /ID# 221466	Roeselare	West-Vlaanderen
Belgium	Vitaz /Id# 229861	Sint-Niklaas
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 231161	Pleven
Bulgaria	UMHAT Sveti Georgi /ID# 231053	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 231028	Sofia
Bulgaria	UMHAT Alexandrovska EAD /ID# 231056	Sofiya	Sofia
Canada	Royal Victoria Hospital /ID# 222636	Barrie	Ontario
Canada	Juravinski Cancer Centre /ID# 221752	Hamilton	Ontario
Canada	Lakeridge Health - Oshawa /ID# 222080	Oshawa	Ontario
Canada	CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754	Quebec City	Quebec
Canada	Niagara Health System /ID# 230994	St Catharines	Ontario
Croatia	Klinicki bolnicki centar Split /ID# 230796	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 230795	Zagreb	Grad Zagreb
Croatia	Klinicka bolnica Merkur /ID# 231155	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 230793	Zagreb	Grad Zagreb
France	Chu Angers /Id# 219115	Angers
France	Hopital Avicenne - APHP /ID# 221286	Bobigny	Ile-de-France
France	Centre Hospitalier de CHAMBERY /ID# 224506	Chambery	Savoie
France	CHU de Nantes, Hotel Dieu -HME /ID# 219113	Nantes	Pays-de-la-Loire
France	CHU NIMES - Hopital Caremeau /ID# 219114	Nimes CEDEX 9	Gard
France	AP-HP - Hopital Necker /ID# 231318	Paris
France	AP-HP - Hopital Saint-Louis /ID# 221288	Paris
France	CHU Bordeaux - Hopital Haut Leveque /ID# 222518	Pessac	Gironde
France	HCL - Hopital Lyon Sud /ID# 222913	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	CH Roubaix - Hopital Victor Provo /ID# 219116	Roubaix Cedex 1	Hauts-de-France
France	ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978	Strasbourg Cedex
Germany	Universitaetsklinikum Aachen /ID# 221519	Aachen	Nordrhein-Westfalen
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347	Dresden	Sachsen
Germany	Universitaetsklinikum Essen /ID# 221522	Essen
Germany	OncoResearch Lerchenfeld GmbH /ID# 230867	Hamburg
Germany	Universitatsklinikum Mannheim /ID# 221523	Mannheim	Baden-Wuerttemberg
Germany	Haemato-Onkologie /ID# 221061	Muenchen	Bayern
Germany	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520	Munich
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786	Athens
Greece	General Hospital of Athens Laiko /ID# 230785	Athens	Attiki
Greece	University General Hospital Attikon /ID# 230784	Athens	Attiki
Israel	Assaf Harofeh Medical Center /ID# 222957	Be'Er Ya'Akov
Israel	Rambam Health Care Campus /ID# 219120	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 219110	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 221374	Kfar Saba
Israel	The Chaim Sheba Medical Center /ID# 219137	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 219134	Tel Aviv-Yafo	Tel-Aviv
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907	Bergamo
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867	Bologna
Italy	ASST Spedali civili di Brescia /ID# 241273	Brescia
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085	Catania
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 219086	Florence
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083	Rome	Lazio
Italy	ASST Sette Laghi /ID# 219084	Varese
Japan	Juntendo University Hospital /ID# 221405	Bunkyo-ku	Tokyo
Japan	Nippon Medical School Hospital /ID# 221674	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 239345	Chiba-shi	Chiba
Japan	University of Yamanashi Hospital /ID# 221701	Chuo-shi	Yamanashi
Japan	Kyushu University Hospital /ID# 221783	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 222752	Fukushima-shi	Fukushima
Japan	Kansai Medical University Hospital /ID# 221482	Hirakata-shi	Osaka
Japan	Hitachi General Hospital /ID# 240048	Hitachi-shi	Ibaraki
Japan	Juntendo University Shizuoka Hospital /ID# 221782	Izunokuni-shi	Shizuoka
Japan	Kanazawa University Hospital /ID# 238424	Kanazawa-shi	Ishikawa
Japan	Medical Corporation Seijinkai Ikeda Hospital /ID# 242172	Kanoya-shi	Kagoshima
Japan	National Cancer Center Hospital East /ID# 226093	Kashiwa-shi	Chiba
Japan	Kobe University Hospital /ID# 246236	Kobe-shi	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center /ID# 222333	Koshigaya-shi	Saitama
Japan	Kawasaki Medical School Hospital /ID# 221481	Kurashiki-shi	Okayama
Japan	Kurashiki Central Hospital /ID# 221692	Kurashiki-shi	Okayama
Japan	Kyoto University Hospital /ID# 238423	Kyoto-shi	Kyoto
Japan	Gunma University Hospital /ID# 221480	Maebashi-shi	Gunma
Japan	Gunmaken Saiseikai Maebashi Hospital /ID# 242806	Maebashi-shi	Gunma
Japan	University of Miyazaki Hospital /ID# 221483	Miyazaki-shi	Miyazaki
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100	Nagoya-shi	Aichi
Japan	Ogaki Municipal Hospital /ID# 240173	Ogaki-shi	Gifu
Japan	Kindai University Hospital /ID# 221479	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital /ID# 242667	Sapporo-shi	Hokkaido
Japan	Osaka University Hospital /ID# 221478	Suita-shi	Osaka
Japan	Ehime University Hospital /ID# 221443	Toon-shi	Ehime
Japan	Fujita Health University Hospital /ID# 221537	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 221664	Tsu-shi	Mie
Korea, Republic of	Inje University Busan Paik Hospital /ID# 231667	Busan
Korea, Republic of	Pusan National University Hospital /ID# 222087	Busan
Korea, Republic of	Kyungpook National University Hospital /ID# 231666	Daegu
Korea, Republic of	Gachon University Gil Medical Center /ID# 222089	Incheon
Korea, Republic of	Seoul National University Bundang Hospital /ID# 219053	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 219054	Seoul
Korea, Republic of	Samsung Medical Center /ID# 221068	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 219055	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056	Seoul
Netherlands	Albert Schweitzer Ziekenhuis /ID# 224015	Dordrecht	Zuid-Holland
Netherlands	Universitair Medisch Centrum Groningen /ID# 218947	Groningen
Netherlands	Radboud Universitair Medisch Centrum /ID# 218948	Nijmegen	Gelderland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 218949	Utrecht
New Zealand	Middlemore Clinical Trials /ID# 230770	Papatoetoe	Auckland
Russian Federation	Moscow State budget healthcare /ID# 221025	Moscow	Moskva
Russian Federation	Republican hospital named after V.A. Baranov /ID# 221412	Petrozavodsk
Russian Federation	Clinic UZI 4D /ID# 221024	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Leningrad Regional Clinical Hospital /ID# 221028	Saint Petersburg
Russian Federation	Almazov National Medical Research Centre /ID# 221033	Sankt-Peterburg
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029	Sankt-Peterburg
Russian Federation	Tula Regional Clinical Hospital /ID# 221027	Tula
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 230946	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 230854	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 230855	Kragujevac	Sumadijski Okrug
Serbia	Clinical Center Vojvodina /ID# 230853	Novi Sad	Vojvodina
South Africa	Wits Clinical Research Site /ID# 232071	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 232072	Johannesburg	Gauteng
South Africa	Albert Alberts Stem Cell Transplant Centre /ID# 232073	Pretoria	Gauteng
Spain	Hospital Universitario Germans Trias i Pujol /ID# 229936	Badalona	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 220913	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 229690	Barcelona
Spain	Hospital Universitario Dr. Negrin /ID# 220897	Las Palmas de Gran Canaria	Las Palmas
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 229691	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 220877	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 220878	Malaga
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720	Pamplona	Navarra
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 222264	Santiago de Compostela	A Coruna
Spain	Hospital Clinico Universitario de Valencia /ID# 220875	Valencia
Sweden	Sahlgrenska University Hospital /ID# 218776	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University Hospital Lund /ID# 220835	Lund	Skane Lan
Sweden	Orebro Universitetssjukhuset /ID# 220829	Orebro	Orebro Lan
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 218984	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 218978	Taichung City
Taiwan	Chi Mei Hospital - Liouying /ID# 221145	Tainan City
Taiwan	National Taiwan University Hospital /ID# 218976	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 221146	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 218983	Taoyuan City
Turkey	Hacettepe University Medical Faculty /ID# 230759	Ankara
Turkey	Trakya University Medical Facu /ID# 230754	Edirne, Istanbul
Turkey	Bagcilar Medipol Mega Universite Hastanesi /ID# 230757	Istanbul
Turkey	Ege University Medical Faculty /ID# 230753	Izmir
Turkey	Inonu University Medical Faculty /ID# 230758	Malatya
Ukraine	Communal non-profit enterprise Regional Center of Oncology /ID# 230832	Kharkiv
Ukraine	Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370	Kyiv
Ukraine	Medical Center "OK!Clinic+" /ID# 230834	Kyiv
Ukraine	SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833	Lviv
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 221333	Birmingham
United Kingdom	United Lincolnshire Hospitals NHS Trust /ID# 231471	Lincoln	Lincolnshire
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 219185	London	London, City Of
United Kingdom	The Christie Hospital /ID# 219191	Manchester
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 219192	Oxford	Oxfordshire
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658	Ann Arbor	Michigan
United States	Emory University /ID# 221562	Atlanta	Georgia
United States	Augusta University Georgia Cancer Center /ID# 221551	Augusta	Georgia
United States	Lynn Cancer Institute, Boca /ID# 230687	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center /ID# 224261	Boston	Massachusetts
United States	Dana-Farber Cancer Institute /ID# 218010	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 221559	Boston	Massachusetts
United States	Gabrail Cancer Center Research /ID# 230488	Canton	Ohio
United States	Rush University Medical Center /ID# 221581	Chicago	Illinois
United States	Oncology Hematology Care, Inc. /ID# 222556	Cincinnati	Ohio
United States	Columbus Regional Research Institute /ID# 227272	Columbus	Georgia
United States	The Ohio State University /ID# 221584	Columbus	Ohio
United States	Minnesota Oncology Hematology /ID# 227357	Edina	Minnesota
United States	Virginia Cancer Specialists - Fairfax /ID# 242682	Fairfax	Virginia
United States	University of Kansas Cancer Center /ID# 218144	Fairway	Kansas
United States	Florida Cancer Specialist - South /ID# 221726	Fort Myers	Florida
United States	Providence Medical Foundation /ID# 241646	Fullerton	California
United States	Hackensack Univ Med Ctr /ID# 221654	Hackensack	New Jersey
United States	University of Texas MD Anderson Cancer Center /ID# 217994	Houston	Texas
United States	Indiana Blood & Marrow Transpl /ID# 221586	Indianapolis	Indiana
United States	MidAmerica Division, Inc. /ID# 221743	Kansas City	Missouri
United States	Thompson Cancer Survival Ctr /ID# 231689	Knoxville	Tennessee
United States	Moores Cancer Center at UC San Diego /ID# 218012	La Jolla	California
United States	Northwell Health - Monter Cancer Center /ID# 222996	Lake Success	New York
United States	Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562	Littleton	Colorado
United States	Weill Cornell Medical College /ID# 220933	New York	New York
United States	Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204	Normal	Illinois
United States	UPMC Hillman Cancer Ctr /ID# 218134	Pittsburgh	Pennsylvania
United States	Florida Cancer Specialists - North /ID# 221727	Saint Petersburg	Florida
United States	University of Utah /ID# 221009	Salt Lake City	Utah
United States	Utah Cancer Specialists Salt Lake Clinic /ID# 221961	Salt Lake City	Utah
United States	VA Puget Sound Health Care System /ID# 231691	Seattle	Washington
United States	Highlands Oncology Group, PA /ID# 221824	Springdale	Arkansas
United States	Texas Oncology - Northeast Texas /ID# 241813	Tyler	Texas
United States	Florida Cancer Specialists - East /ID# 221728	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  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	Change 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% (SVR35)	Reduction in spleen volume is measured by MRI or CT, per IWG criteria.	Baseline (Week 0) Up to Week 96
Secondary	Duration of 35% Spleen Volume Reduction (SVR35)	Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).	Baseline (Week 0) Up to Week 96
Secondary	Change In Fatigue	Change in fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 7a.	Baseline (Week 0) Up to Week 24
Secondary	Change in Physical Functioning	Change in 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 24
Secondary	Percentage of Participants who achieve Anemia Response	The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.	Baseline (Week 0) Up to Week 96
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause.	Up To approximately 8 Years
Secondary	Leukemia-Free Survival	Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.	Up To approximately 8 Years
Secondary	Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis	Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.	Baseline (Week 0) Up to Week 96

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