Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients...
Monoclonal B-Cell LymphocytosisChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma2 moreD1. Primary Objective: 1. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies D2. Secondary Objectives: Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
Study of Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation
Hematologic MalignanciesNonmalignant Diseases6 moreFludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.
Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
Hematologic MalignanciesThis is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.
A Prospective Registry for Febrile Events in Patients With Malignant Hemopathies or Subjected to...
Hematological MalignanciesStem Cell TransplantationHema e-chart is an electronic case record that can be changed in real time and is based on the chronological organisation of the infective events and the therapies prescribed. It allows the collection of all personal, epidemiological, diagnostic and therapeutic data pertaining to the patient, processing it and analysing the results. Aims and objectives of the project The aims of this registry are: To assess how many suspected fungal-related febrile episodes identify an infective fungal agent To have a clear view of the diagnostic and therapeutic actions in the management of onco-haematological patients with suspected fungal-related febrile episodes To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant planning Perform drug-epidemiology relationship analyses, observe toxicity and interactions with antifungal therapies by means of the creation of a national database of fungal infections in patients affected by malignant haemopathies Design A multicentre, prospective registry for monitoring invasive fungal infections in onco-haematological patients Registration criteria: patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes . The recording of consecutive febrile events is required Data collection for each individual patient will be performed according to the method shown in the enclosed flow chart. In the case of a new episode for an existing patient, said new episode will be recorded in the same case record as a new event. All collected data will be coded into the database Information relating to about 500 suspected fungal-related febrile events requiring antifungal therapy is expected to be collected from approximately 60 centres over the course of 18 months Data collection for each event may be performed following the provision of written informed consent, which will be obtained from each patient participating in this health survey The data collected will be handled and stored in full compliance with the Italian laws governing privacy Hema e-chart is a non-interventional registry
The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers...
Chronic Myeloid LeukemiaHealthy2 moreAllogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H(2)] or [U-(13)C(9)]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. [6,6-(2)H(2)] or [U-(13)C(9)]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Research-Action in Hematology From Hospitalization to Home
Hematologic CancerObjective : To study and support the hospitalization and the return home of patients with the help of a psychological follow-up started in a hospital institution and which will continue in the patient's home, based on the concepts of transitionality and narrativity. Material and method To do this, the subjects will benefit from psychological interviews where they will freely discuss what concerns them, whether it is illness, treatment, returning home, or any other personal subject. They will be divided into two groups of 5 patients each, one of the groups will benefit from follow-up in an institution as contracted for several years between the Institute of Hematology and the psychologists of the UMDSP, another from the same follow-up but with the presence of the psychologist at the time of discharge extended to the patient's home after leaving the hospital for a period of 2 months. To ensure a certain consistency in the evaluation criteria, these will be standardized in the form of questionnaires completed blindly by the patient, a caregiver and the investigator, at 3 key times of the research (entry, discharge from hospital, two months after this discharge) Device tested: The aim of this work is to test the benefits of a device based on transitionality, which can limit, thanks to the restoration of the symbolization process, the deleterious effects of each of the stages imposed by the disease, the care and the resumption of autonomy once the active phase of care has passed. Narrativity is also at the heart of this transitional device. It makes it possible to evoke the present experience of the patient in connection with future projects and in the continuity of past, potentially traumatic events. It opens onto a dynamic temporal perspective where the trauma freezes. The whole process promotes the subjective reappropriation of the experience and a psychic well-being.
Central Venous Access Device Removal in Cancer Patients
OncologyHaematological MalignancyBackground: Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective. The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population. Trial objectives: The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years. The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device. At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.
Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
Hematological Malignancy (Leukemia- Lymphoma)investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy
Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients...
Advanced Systemic MastocytosisAggressive Systemic Mastocytosis2 moreBLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.
CAR-T Cell Therapy in Patients With Hematological Malignancies
CART TherapyThe prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.