Clinical Research Directory

Phase 1/ Phase 2 Study to Assess Safety and Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis

This study aims to assess the safety and efficacy of orally administered JBI-802 in subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/ Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis. Who is it for? You may be eligible to join this study if you are aged 18 years and over have been diagnosed with Essential Thrombocythemia and either a Morphologically confirmed diagnosis of Myeloproliferative Neoplasms (MPN) or Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN). Study details: Participants in this study will receive JBI-802 administered orally daily for a 28 day treatment cycle for up to 2-years as long as the participant experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease, unacceptable toxicity, or other reasons for study discontinuation. The starting dose of the study drug is 5 mg/day, a total dose of 35 mg. Dose escalation will occur as per the 3+3 design after an internal Safety Review Committee (SRC) review of each dose stage. Dose expansion to other subtypes of MPN and MDS/MPN will occur after Recommended Phase 2 Dose is determined from the dose escalation phase. Eligibility/Screening for this study will occur within 21 days prior to starting treatment. If the study is suitable for you, you will enter the treatment period. The dose level selected for evaluation in Phase 2 will only be selected if it was safe and well tolerated during Phase 1. The treatment cycles will continue until you wish to stop, or you do not tolerate JBI-802 treatment, Some of the study procedures that include during your treatment period are :Medical, surgical, and cancer history, Height and weight, Physical examination, Vital signs, Eastern Cooperative Oncology Group (ECOG) evaluation, Electrocardiogram, Myeloproliferative neoplasm symptom assessment questionnaire,CT/MRI scan, Bone marrow biopsy, medication usage, Side effects assessment, blood and urine Sampling , liver and thyroid function tests, haematology and coagulation tests, Participants will be followed-up at the start and end of each 28-day cycle to assess safety and tolerability Blood samples will be collected to assess safety and tolerability during the study. After the end of study, subjects will be treated in accordance with local practice. Compassionate use of JBI-802 may be allowed in subjects after study completion, based on the Investigator's judgment in consultation with the Sponsor and on a case-by-case basis. Compassionate use will be controlled by a separate protocol or process as defined by the local regulatory authorities. Continuation of study therapy beyond 2 years may be approved by the Sponsor based on the safety profile and will be contingent on the continued availability of product.

Exercise Training in Patients With Myeloproliferative Neoplasms

The investigators will investigate the response of an individualized exercise training program on quality of life, cardiorespiratory fitness and disease-specific markers in patients with myeloproliferative neoplasms (MPN). To this end, the investigators will randomly assign patients with MPN to a training group and a waiting control group. The training group will undergo an individually tailored exercise training program for three months, while the control group will maintain their usual lifestyle for three months and then has the opportunity to undergo the three-month intervention program. At the beginning and at the end of the three-month intervention phase, the investigators will evaluate physical performance, daily physical activity, muscular strength, and self-reported outcomes and compare them between the training and the control group, in order to assess potential benefits of the exercise training program.

Hematological Disorders in EHPVO Patients

This study focuses on patients who have a condition called extrahepatic portal vein obstruction (EHPVO), where a blood clot blocks the portal vein outside the liver. This blockage can cause problems like an enlarged spleen, bleeding from swollen veins in the digestive system, and low blood cell counts. Many of these patients may have hidden blood disorders that increase the risk of clotting, such as myeloproliferative neoplasms (MPNs), antiphospholipid syndrome (APS), or paroxysmal nocturnal hemoglobinuria (PNH). This study will collect and analyze blood test results-such as complete blood count (CBC), liver function tests (LFTs), and clotting tests-from patients with EHPVO. The aim is to find patterns that may suggest an underlying blood disorder, even if the patient doesn't show obvious symptoms.By understanding these patterns early, doctors may be able to diagnose and treat the root causes of clotting in these patients more accurately, helping prevent complications and improve outcomes.

Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients With Aspirin Resistance

Patients with myeloproliferative neoplasm (MPN) could have laboratory aspirin resistance and then increasing dose of aspirin from once daily to twice daily regimen is suggested. However, it is not routinely recommended to perform platelet function testing to determine aspirin resistance in MPN patients. Moreover, it is not known whether increasing dose of aspirin would always correct aspirin resistance and significantly prevent the thrombotic events in MPN patients. Therefore, this study aims to compare the efficacy of once daily versus twice daily aspirin in high-risk MPN patients with aspirin resistance. MPN patients with laboratory aspirin resistance will be included in this prospective randomized study and platelet function testing will be repeated at one and six months later. Clinical thrombosis and side effect from aspirin will be recorded for at least 2 years after intervention.