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Polycythemia clinical trials

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NCT ID: NCT03065400 Completed - Clinical trials for Primary Myelofibrosis

PD-1 Inhibition in Advanced Myeloproliferative Neoplasms

Start date: June 14, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the effectiveness of a drug called pembrolizumab in patients with Myeloproliferative Neoplasm (MPN); chronic phase (MF-CP), accelerated phase (MPN-AP), or blast phase (MF-BP). Myelofibrosis neoplasm (MPN) is a group of diseases of the bone marrow in which excessive cells are produced. Pembrolizumab also known as Keytruda is a drug that has recently been approved in the United Stated by the Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma and disease progression. Pembrolizumab is experimental in the treatment of MPN. The researchers want to find out what effects, good and /or bad it has on participants and the disease. Participants qualify to take part in this research study if have been diagnosed with a MPN blood disorder called myelofibrosis (MF). Accelerated (10-19% blasts in the blood or bone marrow) and blast phase (>20% blasts in the blood or bone marrow) MPN has been a difficult disease to treat. The term "blasts" refers to immature cells found in the bone marrow. They are not fully developed, and therefore, do not yet carry out any particular function within the body. Funds for conducting this research are provided by Merck and Company, the manufacturer of the study drug pembrolizumab.

NCT ID: NCT03008642 Completed - Polycythemia Clinical Trials

CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia

Poly-CO
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has been used in the vast majority of studies in sport medicine. However, this method has never been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The standard procedure to evaluate the red cell mass is based on isotopic measurement using Cr51-labelled red cells, but its lack of availability in many centers highlights the need for a non-invasive and rapid alternative method. The purpose of this study is to evaluate and validate the CO-Rebreathing method in this set of indications.

NCT ID: NCT03003325 Completed - Polycythemia Vera Clinical Trials

The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV

Low-PV
Start date: February 2, 2017
Phase: Phase 2
Study type: Interventional

The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years and without prior vascular events), in term of control of recommended level of hematocrit < 45%, over a period of 12 months.

NCT ID: NCT02966353 Completed - Clinical trials for Primary Myelofibrosis

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

REALISE
Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

NCT ID: NCT02912884 Completed - Polycythemia Vera Clinical Trials

Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure

MPNClot
Start date: September 2016
Phase:
Study type: Observational

Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality. Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state. Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs. To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.

NCT ID: NCT02897297 Recruiting - Clinical trials for Primary Myelofibrosis

Myeloproliferative Neoplastic Diseases Observatory From Brest

OBENE
Start date: September 2015
Phase:
Study type: Observational

All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study. Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis. This is a not interventional study. Alive patients need to sign a non-opposition consent form. Patients will be followed until last news (death, change of reference centre...).

NCT ID: NCT02893410 Completed - Polycythemia Vera Clinical Trials

Drug Observance and Side Effects of Cytoreductive Drugs in PV and ET Patients

OUEST
Start date: December 2014
Phase:
Study type: Observational

Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential thrombocythemia completed an unique paper questionnaire in order to describe their observance, the side effects and their own appreciation of the taken drug.

NCT ID: NCT02871323 Withdrawn - Clinical trials for Primary Myelofibrosis

Durvalumab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis

Start date: November 2016
Phase: Phase 1
Study type: Interventional

The main purpose of this investigational research study is to determine how safe and tolerable the study drug, MEDI4736 (Durvalumab), is in patients with myelofibrosis (MF). The study drug belongs to a group of drugs called immune checkpoint inhibitors, which have shown promise in other forms of cancer, such as melanoma and lung cancer. One of the effects that this drug has is to activate the patient's own natural immune system. The purpose of this study is to examine the safety and tolerability of the study drug, to study how effective it is at treating patients with myelofibrosis, and to explore how certain markers in the patient's blood and/or bone marrow may be affected by the study drug.

NCT ID: NCT02823184 Completed - Polycythemia Vera Clinical Trials

Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

PhiNESS
Start date: April 27, 2017
Phase:
Study type: Observational

The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

NCT ID: NCT02809274 Not yet recruiting - Polycythemia Vera Clinical Trials

Incidence of Iron Deficiency in Polycythemia Vera (PV) and Association With Disease Features

Start date: July 2016
Phase: N/A
Study type: Observational

Iron deficiency is a known feature of PV, occurs because of accelerated erythropoiesis, gastrointestinal blood loss and phlebotomy. Incidence and effect of iron deficiency in these patients is not well characterized. The study will assess the incidence of iron deficiency at diagnosis and during the course of PV, assess effect of iron deficiency on patient symptoms and its correlation with disease features. This is a multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients >18 years old) of patients who have been diagnosed with PV and are being followed in either community or academic medical centers in Israel.