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:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 53 Locations for this study

See Locations Near You

Local Institution - 0069
Newport Beach California, 92663, United States
Local Institution - 0090
Lake Mary Florida, 32746, United States
Local Institution - 0043
New Orleans Louisiana, 70112, United States
Local Institution - 0038
Worcester Massachusetts, 01655, United States
Local Institution - 0033
Ann Arbor Michigan, 48109, United States
Local Institution - 0045
Hackensack New Jersey, 07601, United States
Local Institution - 0076
Chapel Hill North Carolina, 27514, United States
Local Institution - 0042
Pittsburgh Pennsylvania, 15224, United States
Local Institution - 0036
Blacktown New South Wales, 2148, Australia
Local Institution - 0032
Wollongong New South Wales, 2500, Australia
Local Institution - 0007
East Melbourne Victoria, 3002, Australia
Local Institution - 0006
Heidelberg Victoria, 3084, Australia
Local Institution - 0041
Nedlands Western Australia, 6009, Australia
Local Institution - 0015
West Perth Western Australia, 6005, Australia
Local Institution - 0030
Brest , 29200, France
Local Institution - 0008
Marseille , 13273, France
Local Institution - 0027
Nice , 06202, France
Local Institution - 0011
Paris , 75010, France
Local Institution - 0010
Villejuif , 94800, France
Local Institution - 0039
Essen Nordrhein-Westfalen, 45122, Germany
Local Institution - 0035
Halle Sachsen-Anhalt, 06120, Germany
Local Institution - 0040
Chemnitz Sachsen, 09116, Germany
Local Institution - 0050
Lübeck Schleswig-Holstein, 23538, Germany
Local Institution - 0068
Erding , 85435, Germany
Local Institution - 0061
Chaidari Attikí, 12462, Greece
Local Institution - 0047
Thessaloniki Thessaloníki, 570 1, Greece
Local Institution - 0073
Szeged Csongrád, 6725, Hungary
Local Institution - 0072
Nyiregyhaza Szabolcs-Szatmár-Bereg, 4400, Hungary
Local Institution - 0075
Budapest , 1088, Hungary
Local Institution - 0074
Debrecen , 4032, Hungary
Local Institution - 0086
Be'er Sheva HaDarom, 84101, Israel
Local Institution - 0016
Jerusalem , 91120, Israel
Local Institution - 0018
Petah-Tikva , 49100, Israel
Local Institution - 0017
Ramat Gan , 52621, Israel
Local Institution - 0019
Tel Aviv , 64239, Israel
Local Institution - 0003
Bologna , 40138, Italy
Local Institution - 0002
Brescia , 25123, Italy
Local Institution - 0001
Firenze , 50134, Italy
Local Institution - 0012
Verona , 37134, Italy
Local Institution - 0049
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Local Institution - 0048
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Local Institution - 0053
Seoul Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of
Local Institution - 0077
Słupsk Pomorskie, 76-20, Poland
Local Institution - 0062
Gdańsk , 80-95, Poland
Local Institution - 0052
Bucuresti Cluj, 02232, Romania
Local Institution - 0083
Bucuresti , 05009, Romania
Local Institution - 0051
Cluj , 40001, Romania
Local Institution - 0020
Badalona Barcelona [Barcelona], 08916, Spain
Local Institution - 0054
Madrid Madrid, Comunidad De, 28034, Spain
Local Institution - 0026
Madrid , 28041, Spain
Local Institution - 0021
Salamanca , 37007, Spain
Local Institution - 0029
Santander , 39008, Spain
Local Institution - 0094
València , 46026, Spain

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:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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