An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)81 enrolled

Overview

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies').

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thrombocythemia, Essential Primary Myelofibrosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978). * In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat. Exclusion Criteria: Exclusion Criteria include, but are not limited to: * Ongoing participation in another investigational study (except observational studies). * A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted). * Current use of a prohibited medication (e.g., romiplostim). * Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol. * Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. * Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

Locations (19)

University of Miami Leonard M. Miller

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

UMPC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Universittsklinikum Essen

Essen, Germany

...and 9 more locations

Outcomes

Primary Outcomes

Percentage of Participants Who Experience an Adverse Event (AE)

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.

Time frame: Up to ~32 months

Percentage of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to ~32 months

Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF.

Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.

Time frame: Baseline and Days 169, 339, 509, 679, 849 and 924

Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events

Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to \<= 400 K/uL (400 x 10\^9/L) in the absence of new thromboembolic events is presented.

Time frame: Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648