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.
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
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There are 53 Locations for this study
Newport Beach California, 92663, United States
Lake Mary Florida, 32746, United States
New Orleans Louisiana, 70112, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Hackensack New Jersey, 07601, United States
Chapel Hill North Carolina, 27514, United States
Pittsburgh Pennsylvania, 15224, United States
Blacktown New South Wales, 2148, Australia
Wollongong New South Wales, 2500, Australia
East Melbourne Victoria, 3002, Australia
Heidelberg Victoria, 3084, Australia
Nedlands Western Australia, 6009, Australia
West Perth Western Australia, 6005, Australia
Brest , 29200, France
Marseille , 13273, France
Nice , 06202, France
Paris , 75010, France
Villejuif , 94800, France
Essen Nordrhein-Westfalen, 45122, Germany
Halle Sachsen-Anhalt, 06120, Germany
Chemnitz Sachsen, 09116, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Erding , 85435, Germany
Chaidari Attikí, 12462, Greece
Thessaloniki Thessaloníki, 570 1, Greece
Szeged Csongrád, 6725, Hungary
Nyiregyhaza Szabolcs-Szatmár-Bereg, 4400, Hungary
Budapest , 1088, Hungary
Debrecen , 4032, Hungary
Be'er Sheva HaDarom, 84101, Israel
Jerusalem , 91120, Israel
Petah-Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bologna , 40138, Italy
Brescia , 25123, Italy
Firenze , 50134, Italy
Verona , 37134, Italy
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of
Słupsk Pomorskie, 76-20, Poland
Gdańsk , 80-95, Poland
Bucuresti Cluj, 02232, Romania
Bucuresti , 05009, Romania
Cluj , 40001, Romania
Badalona Barcelona [Barcelona], 08916, Spain
Madrid Madrid, Comunidad De, 28034, Spain
Madrid , 28041, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
València , 46026, Spain
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