Myeloproliferative Neoplasms Clinical Trial

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

Women who are pregnant or breastfeeding at screening
Any significant acute or uncontrolled chronic medical illness

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

216

Study ID:

NCT04817007

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 60 Locations for this study

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Moores Cancer Center-Clinical Trials Office - Hematology
La Jolla California, 92093, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Pooja Motwani, Site 0069
Contact
501-425-4481
Florida Cancer Specialists Lake Mary Drug Development Unit
Lake Mary Florida, 32746, United States More Info
Alexander Philipovskiy, Site 0090
Contact
407-804-6133
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States More Info
Hana Safah, Site 0043
Contact
504-988-6070
Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Zheng Zhou, Site 0082
Contact
617-636-7742
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Gabriela Hobbs, Site 0093
Contact
617-724-3456
University of Massachusetts Medical School-Division of Hematology/Oncology
Worcester Massachusetts, 01655, United States More Info
Jonathan Gerber, Site 0038
Contact
508-635-7093
University Of Michigan
Ann Arbor Michigan, 48109, United States More Info
Moshe Talpaz, Site 0033
Contact
734-647-9913
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
James McCloskey, Site 0045
Contact
551-996-3925
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Aleksander Chojecki, Site 0078
Contact
980-442-4363
AHN West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States More Info
Salman Fazal, Site 0042
Contact
412-578-4355
Lifespan Cancer Institute
Providence Rhode Island, 02906, United States More Info
John Reagan, Site 0071
Contact
401-444-5435
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Alexander Coltoff, Site 0087
Contact
631-487-7301
Mays Cancer Center
San Antonio Texas, 78229, United States
Local Institution - 0036
Blacktown New South Wales, 2148, Australia More Info
Site 0036
Contact
Local Institution - 0032
Wollongong New South Wales, 2500, Australia More Info
Site 0032
Contact
Local Institution - 0007
East Melbourne Victoria, 3002, Australia More Info
Site 0007
Contact
Local Institution - 0006
Heidelberg Victoria, 3084, Australia More Info
Site 0006
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Local Institution - 0041
Nedlands Western Australia, 6009, Australia More Info
Site 0041
Contact
Local Institution - 0015
West Perth Western Australia, 6005, Australia More Info
Site 0015
Contact
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan-Institut de cancérologie et héma
Brest , 29200, France More Info
Jean-Christophe IANOTTO, Site 0030
Contact
+33298223786
Institut Paoli-Calmettes-Hematology
Marseille , 13273, France More Info
Jerome Rey, Site 0008
Contact
33491223481
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology
Nice , 06202, France More Info
Michael Loschi, Site 0027
Contact
33492035841
Hôpital Saint-Louis-Centre d'Investigations Cliniques
Paris , 75010, France More Info
Jean-Jacques Kiladjian, Site 0011
Contact
0142499429
Gustave Roussy-DITEP
Villejuif , 94800, France More Info
Vincent Ribrag, Site 0010
Contact
33142114507
Local Institution - 0039
Essen Nordrhein-Westfalen, 45122, Germany More Info
Site 0039
Contact
Local Institution - 0040
Chemnitz Sachsen, 09116, Germany More Info
Site 0040
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Local Institution - 0050
Lübeck Schleswig-Holstein, 23538, Germany More Info
Site 0050
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Local Institution - 0068
Erding , 85435, Germany More Info
Site 0068
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Local Institution - 0035
Halle (Saale) , 06120, Germany More Info
Site 0035
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Local Institution - 0061
Chaidari Attikí, 12462, Greece More Info
Site 0061
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Local Institution - 0047
Thessaloniki Thessaloníki, 570 1, Greece More Info
Site 0047
Contact
Local Institution - 0086
Be'er Sheva HaDarom, 84101, Israel More Info
Site 0086
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Local Institution - 0016
Jerusalem , 91120, Israel More Info
Site 0016
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Local Institution - 0018
Petah-Tikva , 49100, Israel More Info
Site 0018
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Local Institution - 0017
Ramat Gan , 52621, Israel More Info
Site 0017
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Local Institution - 0019
Tel Aviv , 64239, Israel More Info
Site 0019
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Local Institution - 0003
Bologna , 40138, Italy More Info
Site 0003
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Local Institution - 0002
Brescia , 25123, Italy More Info
Site 0002
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Local Institution - 0001
Firenze , 50134, Italy More Info
Site 0001
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Local Institution - 0012
Verona , 37134, Italy More Info
Site 0012
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Local Institution - 0049
Seongnam KyÇ’nggi-do, 13620, Korea, Republic of More Info
Site 0049
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Local Institution - 0048
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
Site 0048
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Local Institution - 0053
Seoul Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of More Info
Site 0053
Contact
Local Institution - 0063
Kraków Małopolskie, 31-50, Poland More Info
Site 0063
Contact
Local Institution - 0077
SÅ‚upsk Pomorskie, 76-20, Poland More Info
Site 0077
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Local Institution - 0052
Bucuresti Cluj, 02232, Romania More Info
Site 0052
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Local Institution - 0083
București , 05009, Romania More Info
Site 0083
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Local Institution - 0051
Cluj , 40001, Romania More Info
Site 0051
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Local Institution - 0020
Badalona Barcelona [Barcelona], 08916, Spain More Info
Site 0020
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Local Institution - 0054
Madrid Madrid, Comunidad De, 28034, Spain More Info
Site 0054
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Local Institution - 0026
Madrid , 28041, Spain More Info
Site 0026
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Local Institution - 0021
Salamanca , 37007, Spain More Info
Site 0021
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Local Institution - 0029
Santander , 39008, Spain More Info
Site 0029
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Local Institution - 0094
València , 46026, Spain More Info
Site 0094
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Local Institution - 0088
Stanbul Ä°stanbul, 34214, Turkey More Info
Site 0088
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Local Institution - 0079
Ankara , 06100, Turkey More Info
Site 0079
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Local Institution - 0080
Ankara , 06200, Turkey More Info
Site 0080
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Local Institution - 0089
Ä°zmir , 35100, Turkey More Info
Site 0089
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Local Institution - 0081
Izmir , 35340, Turkey More Info
Site 0081
Contact

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

216

Study ID:

NCT04817007

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

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