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Hematologic Diseases clinical trials

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NCT ID: NCT04977739 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Research on the Application and Mechanism of New Biological Probes in Biomedicine

Start date: August 2021
Study type: Observational

Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.

NCT ID: NCT04976205 Recruiting - Clinical trials for Hematological Disease

AI Algorithms to Automate the TMI by VMAT Optimization Using WB-CT/MRI and Synthetic WB-CT - The AuToMI Project

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Total Body Irradiation (TBI) was shown to help in providing immunosuppression that facilitates the donor transplant acceptance. Randomized trials demonstrated that conditioning regimens to bone marrow transplantation (BMT) including TBI have produced better survival rates than chemo-only regimens. The TBI target is represented by the whole BM, and eventually the whole lymphatic system, liver, spleen. The increased life expectancy revealed the occurrence of important toxicities because of full doses received by organs at risk (OARs) and this limited the use of TBI. Many groups have explored the possibility of sophisticated techniques for reducing the dose to healthy tissues while increasing the dose to the BM. These newer approaches aim to generate total marrow (lymph-node) irradiation (TMI/TMLI), sparing as much as possible non-skeletal and non-lymphoid structures. Actually, the time required to optimize a TMI/TMLI plan is 10 days. Therefore, the simulation Computed Tomography (CT) is performed many days before the BMT. Furthermore, the lymph-nodes are defined only on CT images.

NCT ID: NCT04888286 Recruiting - Clinical trials for Hematologic Diseases

DSAs in Patients Undergoing Allo-HSCT From Mismatched Donors

Start date: October 15, 2018
Study type: Observational

Retrospective observational multicentric, spontaneous non-interventional non-pharmacological Italian study. The primary objective is analysis of Anti-HLA antibodies and DSAs searching and monitoring activities in haematological adult and paediatric patients undergoing allo-HSCT from January 2014 to June 2017. This study will evaluate approximately 1000 subjects (with competitive enrolment) from GITMO investigational centers.

NCT ID: NCT04859946 Not yet recruiting - Clinical trials for Hematologic and Lymphocytic Disorder

Itacitinib for the Prevention of Graft Versus Host Disease

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.

NCT ID: NCT04848493 Recruiting - COVID-19 Clinical Trials

National Project on Vaccines, COVID-19 and Frail Patients

Start date: April 19, 2021
Study type: Observational

This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.

NCT ID: NCT04806347 Not yet recruiting - Blood Disease Clinical Trials

Alpha/Beta T-cell Depleted Blood-forming Stem Cell Transplant From Related or Unrelated Donors for Blood Diseases in Children and Young Adults

Start date: August 2021
Phase: Phase 1
Study type: Interventional

This single institution, phase I clinical trial will determine the safety and feasibility of employing T-cell receptor (TCR) αβ+ and CD19+ (Cluster of Differentiation ) depleted hematopoietic stem cell transplantation (HSCT) using peripheral blood stem cells (PBMC) from closely matched unrelated donors or haploidentical donors to treat non-malignant hematologic diseases in children and young adults. Allogeneic hematopoietic stem cell transplantation has become a curative option for children and adolescents with a variety of otherwise fatal conditions. To reduce the incidence and severity of graft-versus-host disease (GVHD) associated with allogeneic hematopoietic stem cell transplantation, donor grafts are depleted of T cells, either using CD34+ selection or CD3+/CD19+ depletion of grafts. However, these selection processes also deplete the graft of protective cell subsets, such as γδ T cells, natural killer(NK) cells, monocytes and dendritic cells, which play important roles in the immune response to infectious agents. Moreover, the presence of NK cells and γδ T in donor grafts is associated with more rapid immune reconstitution after HSCT transplantation. In order to retain these protective immune cell subsets, this trial will use a novel, highly selective graft engineering process using the Miltenyi CliniMACS system that selectively depletes αβ-T cells and B cells which are responsible for GVHD and Epstein Barr Virus (EBV)-related post-transplantation lymphoproliferative disorder, respectively. Prior to transplantation, patients will be treated with a conditioning regimen, specific for the original disorder. The primary objective of this study is evaluation of the safety and feasibility of HSCT using TCRαβ+/CD19+ depleted hematopoietic stem cells to treat non-malignant hematologic diseases. This will be assessed by evaluating the incidence of graft failure, grade III-IV acute GVHD and chronic GVHD and TRM. Secondary objectives include the evaluation of immune reconstitution and incidence of post-transplant infections, adverse events, serious adverse events, overall and disease-free survival and the efficiency of graft processing by the CliniMACS System.

NCT ID: NCT04805216 Recruiting - Covid19 Clinical Trials

Covid-19 Vaccine Response in Immunocompromised Haematology Patients

Start date: March 15, 2021
Study type: Observational

The UK Medicine and Healthcare products Regulatory Agency (MHRA) granted temporary authorisation to three Covid-19 vaccines in December 2020 and January 2021. These vaccinations include: - Covid-19 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine); - ChAdOx1-S vaccine (Astra Zeneca vaccine); - Covid-19 mRNA vaccine (Moderna vaccine). Any other Covid-19 vaccines approved for use by the MHRA in immunocompromised and immunocompetent patients are to be included in this study. The above vaccines have received temporary authorisation after placebo-controlled phase 3 studies confirmed their safety and efficacy in over 100,000 volunteers. People who were immunocompromised or were receiving chemotherapy, radiotherapy or immunoglobulin treatment were excluded from these studies. Safety, efficacy, and durability of antibody response in these studies has been assessed for up to 14 weeks only. These vaccines are being rolled out in the UK and have been recommended for use for immunosuppressed individuals including patients undergoing chemotherapy, immunotherapy, radiotherapy, and those who have undergone stem cell transplantation. Though the MHRA has approved vaccination for immunocompromised patients there is no published evidence to confirm safety and efficacy in these patients. The durability of antibody response and whether this is affected by concurrent chemotherapy, immunotherapy, radiotherapy treatment is also unknown. This observational study aims to evaluate the immune response to Covid-19 vaccines in haematology patients who have immune suppression either due to disease, treatment, or both. The investigators plan to measure Anti-SARS-COV2 IgG antibody levels at specified time points until 120 days after patients have received their 2nd dose of Covid-19 vaccine. The investigators will also collect any adverse events reported by patient including Covid-19 infection or disease after vaccination. The study plans to recruit 50 haematology patients who are clinically assessed by a haematologist as immunosuppressed due to their disease, treatment, or both. The study also plans to recruit 30 healthy (immunocompetent) volunteers who would be the control group for comparison of antibody response and durability.

NCT ID: NCT04763733 Completed - Children Clinical Trials

Laparoscopic Splenectomy in Children

Start date: January 2, 2012
Phase: Phase 1
Study type: Interventional

Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become "golden method" for splenectomy in all ages including children

NCT ID: NCT04737785 Recruiting - Infection Clinical Trials

Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation

Start date: January 1, 2021
Study type: Observational [Patient Registry]

All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients. We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).

NCT ID: NCT04723706 Recruiting - Clinical trials for Hematologic Disorders and Bone Marrow Failure, Hematopoietic Stem Cell Transplantation (HSCT) or Cellular Therapy (CART)

Response to SARS-CoV-2 Vaccine in Stem Cell Transplant and Cellular Therapy Patients

Start date: March 19, 2021
Study type: Observational

For many patients with hematologic disorders and bone marrow failure, hematopoietic stem cell transplantation (HSCT) or cellular therapy (CART) offers a curative treatment option. Patients after SCT or CART have a variable period of immune deficiency in the post-treatment period. The response to vaccination may affect the outcome of the transplant patients. the immunogenicity of vaccines in this immunosuppressed population is uncertain and variable. HSCT and CAR-T recipients are in a COVID-19 high-risk group and conferring immunity by vaccination at the earliest effective timepoint is desirable. At present, the immunogenicity and efficacy of SARS-CoV-2 vaccines in immune-impaired patients including autologous and allogeneic HSCT recipients is unknown. Furthermore, the impact of GvHD and IST on SARS-CoV-2 vaccine immunogenicity is unknown. the investigators aim to evaluate the vaccination response to COVID vaccines after SCT and CART