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Thrombocythemia, Essential clinical trials

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NCT ID: NCT06378437 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of GLB-001 in Patients With Myeloid Malignancies

Start date: May 24, 2024
Phase: Phase 1
Study type: Interventional

Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study.

NCT ID: NCT06361641 Recruiting - Clinical trials for Primary Myelofibrosis

Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes

PHEMOP
Start date: May 29, 2024
Phase: N/A
Study type: Interventional

Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms

NCT ID: NCT06351631 Recruiting - Myelofibrosis Clinical Trials

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Start date: May 23, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: - Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; - Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

NCT ID: NCT06218628 Recruiting - Clinical trials for Chronic Myelomonocytic Leukemia

Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition

Start date: April 5, 2024
Phase: Phase 1
Study type: Interventional

This is a prospective phase I dose-escalation study, with the primary objective to access the MTD and find the RP2D of talazoparib, given in combination with standard of care dosing of pacritinib.

NCT ID: NCT06150157 Recruiting - Neoplasms Clinical Trials

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Start date: December 20, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968, in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s), in part 2 (Cohort Expansion).

NCT ID: NCT06079879 Recruiting - Clinical trials for Essential Thrombocythemia

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)

Start date: December 31, 2023
Phase: Phase 3
Study type: Interventional

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (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 therapy with respect to durable clinicohematologic response (DCHR).

NCT ID: NCT06073847 Recruiting - Clinical trials for Primary Myelofibrosis

A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Start date: July 13, 2023
Phase:
Study type: Observational

The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review & Assessment Service.

NCT ID: NCT06063486 Recruiting - Clinical trials for Myelodysplastic Syndrome

Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates how a curcumin supplement (C3 complex/Bioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation drives disease development and contributes to symptoms experienced by patients with CCUS, LR-MDS, and MPN. Curcumin has been shown to have anti-inflammatory and anti-cancer properties and has been studied in various chronic illnesses and hematologic diseases.

NCT ID: NCT05921838 Recruiting - Clinical trials for Primary Thrombocytosis

The Role of Circ0014614 in the Formation and Development of ET

Start date: January 1, 2021
Phase:
Study type: Observational

Research on the Role of Circ0014614 in the Formation and Development of ET

NCT ID: NCT05883904 Recruiting - Clinical trials for Primary Myelofibrosis

Real World Evidence of Fedratinib Effectiveness in MF

REALFed
Start date: January 29, 2024
Phase:
Study type: Observational

This is a multicenter prospective and retrospective observational clinical study in patients with primary or post polycythemia vera or post essential thrombocythemia myelofibrosis to test the efficacy of fedratinib in the rea world. Participants will be managed according to the clinical practice of the participating Center. All Centers will be Italian Hematology Units belonging to the GIMEMA Organization in Italy.