FREEDOM2: An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03952039
• Collaborator: Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation (Industry)
• Enrollment: 192
• Locations: 118
• Arms: 2
• Anticipated Duration (Months): 69.5
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

Condition or Disease	Intervention/Treatment	Phase
Primary Myelofibrosis; Post-Polycythemia Vera; Myelofibrosis	Drug: FEDRATINIB; Drug: Best Available Therapy (BAT)	Phase 3

Detailed Description

This Phase 3, multicenter, randomized, two-arm, open-label study will include subjects with intermediate or high-risk (as per the DIPSS score) primary myelofibrosis (PMF), postpolycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). This study will be conducted in compliance with International Council for Harmonisation (ICH) Good Clinical Practices (GCPs).

Study design includes:

• A 28-day Screening Period

• 2:1 Randomization to fedratinib or best available therapy (BAT)

• Stratification at Randomization according to:

• Spleen size by palpation: < 15 cm below left costal margin (LCM) versus ≥ 15 cm below LCM

• Platelets ≥ 50 to < 100 x 109/L versus platelets ≥ 100 x 109/L

• Refractory or relapsed to ruxolitinib treatment versus intolerant to ruxolitinib treatment

• Study Treatment Period (time on study drug plus 30 days after last dose)

• Subjects are allowed to crossover from BAT to the fedratinib arm after the Cycle 6 response assessment or before the Cycle 6 response assessment in the event of a confirmed progression of splenomegaly by MRI/CT scan

• A Survival Follow-up Period for progression and survival

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib
• Actual Study Start Date: Sep 9, 2019
• Anticipated Primary Completion Date: Dec 22, 2022
• Anticipated Study Completion Date: Jun 23, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fedratinib 400mg/day Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.	Drug: FEDRATINIB; A potent and selective inhibitor of JAK2 kinase activity
Active Comparator: Best Available Therapy (BAT) Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment.	Drug: Best Available Therapy (BAT); Best available therapy (BAT)

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects who have ≥ 35% SVR at end of cycle 6 [At the end of Cycle 1 (each cycle is 28 days)]

   Spleen volume response rate (RR)

Secondary Outcome Measures

1. Proportion of subjects with ≥ 50% reduction in total symptom scores measured by MFSAF at end of cycle 6 [Up to end of Cycle 6 (each cycle is 28 days)]

   Symptom response rate (SRR)

2. Proportion of subjects who have ≥ 25% reduction in spleen volume at the end of cycle 6 [At the end of Cycle 1 (each cycle is 28 days)]

   Spleen volume response rate (RR25)

3. Adverse Events (AEs) [Up to 30 days post last dose]

   Number of participants with adverse event

4. Proportion of subjects who have ≥ 50% reduction in spleen size by palpation at end of cycle 6 [Up to end of Cycle 6 (each cycle is 28 days)]

   Spleen response rate by palpation (RRP)

5. Durability of Spleen Volume Response by MRI/CT (DR) [Up to end of Cycle 6 (each cycle is 28 days)]

   Is defined as time from the first documented spleen response (ie, ≥ 35% reduction in spleen volume) to the first documented spleen volume reduction < 35%.

6. Duration of ≥ 50 % reduction in spleen size by palpation for subjects with a palpable spleen at least 5 cm below the left costal margin (LCM) at baseline [Up to approximately 30 months]

   From C1D1 until the 30- day follow-up after last dose visit

7. Duration of ≥ 50% reduction in total symptom scores measured by MFSAF [From enrollment until 30 days post last dose]

   Durability of symptoms response (DSR)

8. Time from randomization to death due to any reason or disease progression (modified IWG-MRT 2013 including ≥ 25% increase in spleen volume by MRI/CT) [Up to 24 months from enrollment to End of Survival Follow-up]

   Spleen and disease progression free survival (SDPFS)

9. Gastrointestinal Adverse Events [Up to approximately 30 months]

   Incidence of subjects with Grade 3 or higher Gastrointestinal events (nausea, diarrhea, or vomiting) according to CTCAE v5.0

10. Encephalopathy Events, including Wernicke's [Up to 30 days post last dose]

    Occurrence of confirmed encephalopathy events, including Wernicke's

11. Health-Related Quality of Life (HRQoL) [Up to 30-day follow-up after last dose visit]

    To evaluate Health-Related Quality of Life (HRQoL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30)

12. EQ-5D-5L [Up to 20-day follow-up after last dose visit]

    To evaluate Patient Reported Outcomes (PRO) as measured by the EQ-5D-5L questionnaire

13. Overall Survival (OS) [From randomization to the End of Survival Follow-up (approximately 12 months)]

    Time from randomization to death due to any reason

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is at least 18 years of age at the time of signing the informed consent form (ICF)

2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2

3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-ET or post-PV myelofibrosis according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report

4. Subject has a DIPSS Risk score of Intermediate-2 or High

5. Subject has a measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥ 450 cm3 by MRI or CT-scan and by palpable spleen measuring ≥ 5 cm below the left costal margin

6. Subject has a measurable total symptoms score (≥ 1) as measured by the Myelofibrosis Symptom Assessment Form (MFSAF)

7. Subject has been previously exposed to ruxolitinib, and must meet at least one of the following criteria (a and/or b)

8. Treatment with ruxolitinib for ≥ 3 months with inadequate efficacy response (refractory) defined as < 10% spleen volume reduction by MRI or < 30% decrease from baseline in spleen size by palpation or regrowth (relapsed) to these parameters following an initial response

9. Treatment with ruxolitinib for ≥ 28 days complicated by any of the following (intolerant):

• Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) or

• Grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while on treatment with ruxolitinib

1. Subject must have treatment-related toxicities from prior therapy resolved to Grade 1 or pretreatment baseline before start of last therapy prior to randomization

2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted

3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements

4. A female of childbearing potential (FCBP) must:

5. Have 2 negative pregnancy tests as verified by the Investigator during screening prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.

6. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with highly effective contraception without interruption, -14 days prior to starting investigational product, during the study treatment (including dose interruptions), and for 30 days after discontinuation of study treatment.

Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).

1. A male subject must:

Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 30 days following investigational product discontinuation, or longer if required for each compound and/or by local regulations, even if he has undergone a successful vasectomy

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

2. Platelets < 50 x 109/L

3. Absolute neutrophil count (ANC) < 1.0 x 109/L

4. White blood count (WBC) > 100 x 109/L

5. Myeloblasts ≥ 5 % in peripheral blood

6. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as per the Modification of Diet in Renal Disease [MDRD] formula)

7. Serum amylase or lipase > 1.5 x upper limit of normal (ULN)

8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)

9. Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5 - 3.0 x ULN are eligible if the direct bilirubin fraction is < 25% of the total bilirubin

10. Subject is pregnant or lactating female

11. Subject with previous splenectomy

12. Subject with previous or planned hematopoietic cell transplant

13. Subject with prior history of encephalopathy, including Wernicke's (WE)

14. Subject with signs or symptoms of encephalopathy, including WE (eg, severe ataxia, ocular paralysis or cerebellar signs)

15. Subject with thiamine deficiency, defined as thiamine levels in whole blood below normal range according to the central laboratory and not demonstrated to be corrected prior to randomization

16. Subject with concomitant treatment with or use of pharmaceutical, herbal agents or food known to be strong or moderate inducers of Cytochrome P450 3A4 (CYP3A4), or dual CYP2C19 and CYP3A4 inhibitors

17. Subject on any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, systemic corticosteroids > 10 mg/day prednisone or equivalent. Subjects who have had prior exposure to hydroxyurea (eg, Hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to randomization

18. Subject has received ruxolitinib within 14 days prior to randomization

19. Subject with previous exposure to Janus kinase (JAK) inhibitor(s) other than ruxolitinib treatment

20. Subject on treatment with aspirin with doses > 150 mg daily

21. Subject with major surgery within 28 days prior to randomization

22. Subject with diagnosis of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemochromatosis, non-alcoholic steatohepatitis)

23. Subject with prior malignancy other than the disease under study unless the subject has not required treatment for the malignancy for at least 3 years prior to randomization. However, subject with the following history/concurrent conditions provided successfully treated may enroll: non-invasive skin cancer, in situ cervical cancer, carcinoma in situ of the breast, incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system), or is free of disease and on hormonal treatment only

24. Subject with uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4)

25. Subject with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC)

26. Subject with serious active infection

27. Subject with presence of any significant gastric or other disorder that would inhibit absorption of oral medication

28. Subject is unable to swallow capsule

29. Subject with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

30. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

31. Subject has any condition that confounds the ability to interpret data from the study

32. Subject with participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to randomization

33. Subject with a life expectancy of less than 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
2	Local Institution - 101	Adelaide	South Australia	Australia	5000
3	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
4	Peninsula Private Hospital	Frankston	Victoria	Australia	3199
5	Eastern Health Clinical School	Box Hill		Australia	3128
6	Alfred Hospital	Melbourne		Australia	3004
7	Medical University of Graz	Graz		Austria	A-8036
8	Medical University Innsbruck	Innsbruck		Austria	6020
9	Elisabethinen Hospital Linz	Linz		Austria	4020
10	Salzburger Landkliniken St. Johanns-Spital	Salzburg		Austria	5020
11	Medical University of Vienna	Vienna		Austria	1090
12	Klinikum Wels-Grieskirchen GmbH	Wels		Austria	4600
13	Hanusch Krankenhaus	Wien		Austria	1140
14	AZ Sint-Jan AV Brugge	Brugge		Belgium	8000
15	Cliniques Universitaires Saint-Luc	Bruxelles		Belgium	1200
16	Centre Hospitalier de Jolimont-Lobbes	La Louvière-(Haine St-Paul)		Belgium	7100
17	UZ Leuven	Leuven		Belgium	3000
18	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege		Belgium	4000
19	Cliniques Universitaires UCL de Mont-Godine	Yvoir		Belgium	5530
20	Peking University People's Hospital	Beijing		China	100044
21	Fujian Medical University Union Hospital	Fuzhou		China	350001
22	Guangdong General Hospital	Guangzhou, Guangdong		China	510080
23	Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University	Nanjing		China	210029
24	Chinese Academy of Medical Sciences & Peking Union Medical College	Tianjin		China	300041
25	Local Institution - 553	Tianjin		China	300041
26	Henan Cancer Hospital	Zhengzhou		China
27	Fakultni Nemocnice Brno	Brno		Czechia	625 00
28	Fakultni Nemocnice Ostrava	Ostrava-Poruba		Czechia	708 52
29	Vseobecna Fakultni Nemocnice v Praze	Prague 2		Czechia	128 08
30	CHU d'Angers	Angers		France	49033
31	CHRU de Brest - Hopital Morvan	Brest		France	29200
32	Centre Hospitalier de Lens	Lens Cedex		France	62307
33	CHRU Claude Huriez	Lille		France	59037
34	CHU Nice Hopital de L'Archet 2	Nice Cedex 3		France	06200
35	Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau	Nimes Cedex 9		France	30029
36	Hopital Saint Louis	Paris		France	75010
37	CHRU - Hopital du Haut Leveque	Pessac		France	33604
38	Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud	Pierre-Benite		France	69495
39	CHU La Miletrie	Poitiers Cedex		France	86021
40	CHU Strasbourg - Hopital Civil	Strasbourg		France	67091
41	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse Cedex 9		France	31059
42	Unviversitatsklinikum Aachen	Aachen		Germany	52074
43	Klinikum der Johann Wolfgang Goethe Universitat	Frankfurt am Main		Germany	60590
44	Universitaetsklinikum Halle Saale	Halle		Germany	06120
45	Universitaetsklinikum Jena	Jena		Germany	07747
46	Universitaetsklinikum Magdeburg A oeR	Magdeburg		Germany	39120
47	University of Heidelberg - Universitatsklinikum Mannheim	Mannheim		Germany	68167
48	Johannes Wiesling Klinikum Minden	Minden		Germany	32429
49	Universitaetsklinikum Ulm	Ulm		Germany	89081
50	Semmelweis Egyetem	Budapest		Hungary	1088
51	Petz Aladar Megyei Oktato Korhaz	Gyor		Hungary	9023
52	Local Institution - 602	Kaposvar		Hungary	7400
53	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvar		Hungary	7400
54	SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz	Nyiregyhaza		Hungary	4400
55	Local Institution - 603	Szeged		Hungary	6720
56	Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont	Szeged		Hungary	6720
57	Cork University Hospital	Cork		Ireland
58	Mater Misericordiae University Hospital	Dublin		Ireland	Dublin 7
59	St. James' Hospital	Dublin		Ireland	Dublin 8
60	A.O.U. di Bologna Policlinico S.Orsola-Malpighi	Bologna		Italy	40138
61	ASST Spedali Civili P.O. di Brescia	Brescia		Italy	25123
62	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico	Catania		Italy	95123
63	Azienda Ospedaliero-Universitaria Careggi	Firenze		Italy	50134
64	IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena	Milano		Italy	20122
65	Ospedale Cardarelli	Naples		Italy	80131
66	Fondazione IRCCS Policlinico San Matteo	Pavia		Italy	27100
67	Policlinico Umberto I - Universita La Sapienza	Roma		Italy	00168
68	Universita Cattololica del Sacro Cuore	Roma		Italy	00168
69	Azienda Ospedaliera S. Andrea - Università La Sapienza	Roma		Italy	00189
70	Local Institution - 359	Roma		Italy	00189
71	Azienda Ospedaliera Citta della Salute e della Scienza di Torino	Torino		Italy	10126
72	Local Institution - 355	Torino		Italy	10126
73	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine	Udine		Italy	33100
74	Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese	Varese		Italy	21100
75	Azienda Ospedaliera Universitaria Integrata di Verona	Verona		Italy	37134
76	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
77	Samsung Medical Center	Seoul		Korea, Republic of	06351
78	Seoul St Marys Hospital College of Medicine The Catholic University of Korea	Seoul		Korea, Republic of	137-701
79	Soon Chun Hyang University Hospital Seoul	Seoul		Korea, Republic of	140-887
80	Seoul National University Hospital	Seoul		Korea, Republic of	3080
81	Asan Medical Center	Seoul		Korea, Republic of	5505
82	Local Institution - 902	Seoul		Korea, Republic of	5505
83	UMC Maastricht	Maastricht		Netherlands	6229 HX
84	Radboud University Medical Center	Nijmegen		Netherlands	6525 GA
85	Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan		Poland	60-569
86	Instytut Hematologii i Transfuzjologii w Warszawie	Warszawa		Poland	02-776
87	Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego	Wroclaw		Poland	50-556
88	FSBI Hematology Research Center Ministry of Healthcare of the Russian Federation	Moscow		Russian Federation	125167
89	Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin	Moscow		Russian Federation	125284
90	City Clinical Hospital 40	Moscow		Russian Federation	129301
91	Novosibirsk State Medical University (NSMU)	Novosibirsk		Russian Federation	630066
92	Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency	Saint Petersburg		Russian Federation	191024
93	Pavlov First Saint Petersburg State Medical University	Saint-Petersburg		Russian Federation	197022
94	Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov	St Petersburg		Russian Federation	197341
95	State Budgetary Healthcare Organization	Vladikavkaz		Russian Federation	362002
96	Complejo Hospitalario Universitario A Coruna	A Coruna		Spain	15006
97	Hospital General Universitario de Alicante	Alicante		Spain	03010
98	Hospital Universitari Germans Trias i Pujol	Badalona (Barcelona)		Spain	8916
99	Hospital Universitario Cruces	Barakaldo		Spain	48903
100	Hospital Clinic de Barcelona	Barcelona		Spain	08036
101	Instituto Catalan de Oncologia de Girona	Gerona		Spain	17007
102	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria		Spain	35012
103	Hospital Ramon y Cajal	Madrid		Spain	28034
104	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
105	Hospital Universitario Virgen de la Victoria	Malaga		Spain	29010
106	Local Institution - 457	Malaga		Spain	29010
107	Hospital General Universitario Morales Meseguer	Murcia		Spain	30008
108	Universitario de Salamanca - Hospital Clinico	Salamanca		Spain	37007
109	Hospital Universitario de Tenerife	Santa Cruz de Tenerife		Spain	38320
110	Hospital Clinico Universitario de Santiago	Santiago de Compostela		Spain	15706
111	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
112	University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
113	United Lincolnshire Hospitals NHS Trust	Boston		United Kingdom	PE21 9QS
114	Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital	London		United Kingdom	SE1 9RT
115	Imperial College Hammersmith Hospital	London		United Kingdom	W12 0HS
116	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
117	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB
118	The Churchill Hospital	Oxford		United Kingdom	0X3 7LE

Sponsors and Collaborators

• Celgene
• Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03952039
• Other Study ID Numbers: FEDR-MF-002; U1111-1223-2962; 2018-003411-21
• First Posted: May 16, 2019
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: MF; myeloproliferative neoplasms; MPN; myelofibrosis; PMF; post-PV; Post-Polycythemia Vera; post-ET MF; Post-Essential Thrombocythemia Myelofibrosis
• Additional relevant MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential

Study Results

No Results Posted as of Aug 1, 2022