This is a phase III, multicentre, randomized, controlled, open, parallel group trial in patients with previously untreated CLL. A total of 754 participants will be randomized on a 1:1 basis to receive standard therapy with fludarabine, cyclophosphoamide and rituximab (FCR) or ibrutinib plus rituximab (IR)
|This is a non-interventional study to look at the use of a myeloproliferative neoplasms- symptom assessment form (MPN-SAF) diary in order to assess the patient reported outcomes.
Myeloploliferative neoplasms (MPNs) are associated with a high chance of patients experiencing a range of symptoms affecting many of the body systems. There are few studies that have investigated the effects of standard therapies on symptoms experienced by patients with MPNs.
This study is designed to test the effectiveness of a new questionnaire to collect information about the symptoms experienced by patients with myelopreliferative neoplasms. The questionnaire is in the form of a diary completed by patients. We want to see how well the diary can capture all the information we might need. The study is being organised by the Mayo Clinic in the US.
|The aim of the project is to develop and validate a quality of life questionnaire designed to assess treatment-related PROs in clinical haematological practice. The study will involve mixed qualitative and quantitative methods of interviews and questionnaires.
The study will be carried out in two main stages. Firstly, data will be collected from interviews and developed into a questionnaire. The second stage of the study will involve validating and piloting the questionnaire in patients with haematological malignancies.
The interviews will last approximately 20-30 minutes and will explore how patients’ lives have been affected by their disease. They will be audio recorded.
The first draft of the questionnaire will be pilot tested in a further cohort of patients. The questionnaire items will then be reduced using statistical techniques on a third cohort, and finally validated. Patients with haematological malignancies will be recruited from outpatient clinics or inpatient settings.
The use of such an investment will allow review of a drug in haematological practice and thereby also permit evaluation of it’s effectiveness.
AML 19 will build upon the results of previous trials in acute myeloid leukaemia. It will evaluate several relevant therapeutic questions in patients who are 18-60 years old and suitable for intensive chemotherapy. For patients who do not have the APL subtype, the investigators will evaluate the best way of adding mylotarg to induction chemotherapy. After induction, patients will be characterised based upon their prognosis and may enter different randomisations, the randomisations allow patients to access different treatments based on their disease profile. The investigators will also evaluate whether continued monitoring of patients can improve outcomes and affects quality of like. Patient with the APL subtype will enter a different part of the trial.
|This is an international study conducted in Europe, Canada and Australia that aims to recruit 500 patients worldwide. It is non-interventional, meaning that data documented are routinely collected in daily practice from examinations or diagnostic tests; no additional examinations or tests need to be done.
The observation period for each patient is 6 months from enrollment into the study, or until withdrawal of consent or when no longer contactable.
It is a study of cancer patients with Deep vein thrombosis (DVT; blood clot) and/or Pulmonary Embolism (PE) changing to rivaroxaban for treatment of acute DVT and PE, and prevention of recurrent DVT and PE.
The study aims to collect certain information from patients to help assess how satisfied they are with their treatment of blood clot or blood clot prevention using rivaroxaban therapy.
|10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are for cytopenias. Although we identify a cause in only third of cases of cytopenia, this leaves a significant proportion of patients without an answer.
The hypothesis we will test is that a proportion of patients with idiopathic cytopenias have mutations in myelodysplasic syndrome (MDS) associated genes. We will sequence a panel of known MDS associated genes in patient material (bone marrow and blood) that is sent routinely to the diagnostic service where conventional techniques have failed to establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to determine their survival, blood counts and development of acute leukaemia and other haematological malignancies. The clinical outcomes will be correlated with any mutations detected.
HORIZONS is a cohort study to explore recovery of health and well-being in adults diagnosed with cancer. Experiences and outcomes of cancer treatment and care are changing. A growing number of people are experiencing cancer not as a life-limiting disease, but as a life-changing and long-term condition. There is a growing imperative to understand the changing landscape of cancer and its consequences: as we do so, we will be better able to inform the design and delivery of cost effective interventions that make possible supported self-management, as well as service organization and delivery.
The key research questions are:
What impact does cancer and its treatment have on the lives of people diagnosed with cancer in the short, medium and long term?
What are the health outcomes, experiences and self-management activities over the life-course across different cancer types and who and what influence these?
HORIZONS is a series of prospective cohort studies of adults treated for non-metastatic cancer to capture their health outcomes and experiences from before they begin active treatment and regularly over their life-course. Our initial cancer cohorts will be breast cancer (diagnosed under age 50), non-Hodgkin lymphoma, and gynaecological cancers (ovarian, cervical, uterine). We will start recruitment with three pilot sites in NHS Trusts before rolling out full recruitment to approximately 50 NHS secondary care Trusts. Questionnaires will be completed before treatment (baseline), and followed up at regular intervals.
We will maintain and develop HORIZONS as a national and international resource to explore consequences of different cancer diagnoses and treatments from the individual perspective across the life-course.