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NCT ID: NCT06369389 Not yet recruiting - Hemopathy Clinical Trials

Real-life Management of Patients Eligible for CAR-T Cell Therapy

CARAVAGE
Start date: April 30, 2024
Phase:
Study type: Observational

Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways. With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway. The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million.

NCT ID: NCT06370351 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

AUDIOGENE
Start date: April 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

NCT ID: NCT06370416 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

NCT ID: NCT06370754 Not yet recruiting - Pancreatic Cancer Clinical Trials

Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

FD-IMPACT
Start date: April 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer.

NCT ID: NCT06372340 Not yet recruiting - Clinical trials for Urinary Incontinence

Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2)How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive.

NCT ID: NCT06374498 Not yet recruiting - Clinical trials for Coronary Artery Disease

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that: 1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease. 2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis.

NCT ID: NCT06374888 Not yet recruiting - Clinical trials for Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis

Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.

NCT ID: NCT06375317 Not yet recruiting - Clinical trials for HCC - Hepatocellular Carcinoma

HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.

NCT ID: NCT06378307 Not yet recruiting - Inclusive Education Clinical Trials

A Transferability Study on the Conditions for a Successful Inclusive Education

TIAP
Start date: April 30, 2024
Phase:
Study type: Observational

The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework).

NCT ID: NCT06381453 Not yet recruiting - Clinical trials for Autoimmune Hepatitis

Belimumab in Autoimmune Hepatitis

BELief
Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic & environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability & safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT<2x ULN & corticosteroids at a dose of </= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH.