Myeloproliferative Neoplasms Clinical Trial

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

Summary

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available treatment (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea.

The primary study hypothesis is that bomedemstat is superior to the best available treatment with respect to durable clinicohematologic response (DCHR).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms
Has a bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance: hydroxyurea resistance (or inadequate response) or hydroxyurea Intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
Has a platelet count > 450 × 10^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 10^9/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior lines of therapy including hydroxyurea

Exclusion Criteria:

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT06079879

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 30 Locations for this study

See Locations Near You

Henry Ford Hospital ( Site 3413)
Detroit Michigan, 48202, United States More Info
Study Coordinator
Contact
313-717-5706
Royal Prince Alfred Hospital ( Site 1100)
Camperdown New South Wales, 2050, Australia More Info
Study Coordinator
Contact
+6195158031
Royal North Shore Hospital ( Site 0003)
St Leonards New South Wales, 2065, Australia More Info
Study Coordinator
Contact
02 99264171
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
Adelaide South Australia, 5000, Australia More Info
Study Coordinator
Contact
61870744133
Monash Health-Haematology Research ( Site 0006)
Clayton Victoria, 3168, Australia More Info
Study Coordinator
Contact
+61422611678
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
Melbourne Victoria, 3021, Australia More Info
Study Coordinator
Contact
0407887699
Royal Perth Hospital-Haematology ( Site 0504)
Perth Western Australia, 6000, Australia More Info
Study Coordinator
Contact
+61 8 9224 2405
Queen Mary Hospital ( Site 1901)
Hksar , , Hong Kong More Info
Study Coordinator
Contact
852 22554542
Rambam Health Care Campus ( Site 2102)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247773109
Hadassah Medical Center ( Site 0904)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+972504048732
Sheba Medical Center ( Site 2101)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
972526669167
Sourasky Medical Center ( Site 0902)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
972524266648
Yitzhak Shamir Medical Center. ( Site 0901)
Zerifin , 70300, Israel More Info
Study Coordinator
Contact
97289542443
Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
Ancona , 60126, Italy More Info
Study Coordinator
Contact
0715964771
Nippon Medical School Hospital ( Site 3608)
Bunkyo-ku Tokyo, 113-8, Japan More Info
Study Coordinator
Contact
+81-3-3822-2131
University of Yamanashi Hospital ( Site 3606)
Chuo Yamanashi, 409-3, Japan More Info
Study Coordinator
Contact
+81-55-273-1111
Kyushu University Hospital ( Site 3605)
Fukuoka , 812-8, Japan More Info
Study Coordinator
Contact
+8192-641-1151
University of Miyazaki Hospital ( Site 3609)
Miyazaki , 889-1, Japan More Info
Study Coordinator
Contact
+81-985-85-1510
Seoul National University Bundang Hospital-Hematology ( Site 0605)
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
+82-31-010-787-7038
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
Seoul , 06591, Korea, Republic of More Info
Study Coordinator
Contact
82222586058
North Shore Hospital-Department of Haematology ( Site 0051)
Auckland , 0622, New Zealand More Info
Study Coordinator
Contact
64948689207108
Aotearoa Clinical Trials ( Site 0050)
Auckland , 2025, New Zealand More Info
Study Coordinator
Contact
+6492760044
CHUS - Hospital Clinico Universitario ( Site 0421)
Santiago de Compostela La Coruna, 15706, Spain More Info
Study Coordinator
Contact
034981950549
Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
Madrid Madrid, Comunidad De, 28034, Spain More Info
Study Coordinator
Contact
34913368686
Hospital Universitario 12 de Octubre ( Site 2806)
Madrid , 28041, Spain More Info
Study Coordinator
Contact
913908000
Hospital Universitario Virgen de la Victoria ( Site 0418)
Malaga , 29010, Spain More Info
Study Coordinator
Contact
+34 951032060
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
Salamanca , 37007, Spain More Info
Study Coordinator
Contact
34 923291100 55764
Hospital Universitario Doctor Peset ( Site 0411)
Valencia , 46017, Spain More Info
Study Coordinator
Contact
+34963189168
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
+88662353535
National Taiwan University Hospital ( Site 3101)
Taipei , 10048, Taiwan More Info
Study Coordinator
Contact
+886223123456
Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
Taoyuan , 333, Taiwan More Info
Study Coordinator
Contact
+88633281200

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT06079879

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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