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Hematologic Neoplasms clinical trials

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NCT ID: NCT04673305 Not yet recruiting - Clinical trials for Cognitive Impairment

Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies

Start date: March 2021
Phase: N/A
Study type: Interventional

BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and about 35% continue to present cognitive difficulties in the following months/years. There is growing evidence that cognitive symptoms have a biological mechanism linked to the activation of immunological cytokines that exert important effects on the brain functions. For example, interferon α is known to increase the levels of IL-1, IL-6 and TNF-α, and this increase is associated with memory deficits, executive function and mood alterations. A neurotoxic action induced by cytokines has been demonstrated both in the early stages of the tumor and after chemotherapy. Several imaging studies suggest that the cognitive impairment pattern in cancer patients, during the treatment and in remission, is related to structural and functional brain changes. Longitudinal studies in women with breast cancer treated with chemoterapy have shown a reduction in the volume of cerebral gray matter, mainly in the bilateral frontal cortex and hippocampus. In parallel, diffusion tensor imaging studies have shown an alteration of the integrity of the frontal, parietal and occipital cerebral white matter, demyelination and axonal degeneration processes. Finally, functional magnetic resonance studies in cancer patients have shown alterations in the connectivity of the default mode network compared to control subjects. Studies carried out to date, show a prevalent impairment of executive functions and working memory. Cognitive impairment has been studied mainly as a possible adverse effect in women treated with chemotherapy for breast cancer, while there are few studies in the literature on patients with haematological malignancies. STUDY DESIGN The study is targeted to patients ages ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months. Once the eligibility criteria have been assessed, the hematologist proposes the enrollment in the study. Once the patient's informed consent has been acquired, a neurological examination is carried out, functional tests required by the protocol are administered. The patient begins, as per clinical practice, the treatment provided for his/her haematological malignancy. Test's evaluation is repeated at 6 months and 12 months after the enrollment. In conjunction with neurological tests, will be performed a venipuncture as per clinical practice, and a blood sample is taken to measure the cytokines involved in inflammatory processes. It is expected that a patient can perform up to a maximum of 3 blood samples for the biological study. STATISTICAL ANALYSIS This is a non-pharmacological, prospective, uncontrolled, open-label single-center interventional pilot study, aimed to describ the progress of cognitive function under treatment for haematological disease. Due to the pilot and exploratory nature of the study and the substantial absence of a specific literature relating to the elderly onco-haematological patient, it is not believed that the conditions exist to be able to formally define the size of the sample. The sample size is arbitrarily fixed at 60 patients. The observation time will be 12 months from enrollment.

NCT ID: NCT04662788 Not yet recruiting - Clinical trials for Hematological Malignancies

Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Start date: January 1, 2021
Phase: Early Phase 1
Study type: Interventional

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

NCT ID: NCT04657965 Not yet recruiting - Clinical trials for Hematological Malignancies

LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

Start date: January 15, 2021
Phase: Early Phase 1
Study type: Interventional

A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies

NCT ID: NCT04626908 Not yet recruiting - Clinical trials for Relapsed and Refractory

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

Start date: November 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

NCT ID: NCT04613765 Not yet recruiting - Clinical trials for Hematological Malignancy

A Mixed Method to Study Adherence to Oral Anticancer Medications in a Multilingual and Multicultural Setting

MADESIO
Start date: December 1, 2020
Phase:
Study type: Observational

Patients with haematologic malignancies are increasingly treated by Oral Anticancer Medications (OAMs), increasing the challenge of ensuring optimal adherence to treatment. However, except for Chronic Myelogenous Leukemia (CML) or Acute Lymphoid Leukemia (ALL), the extent of non-adherence has rarely been investigated in an outpatient setting. In Belgium, the only available data suffers from critical underrepresentation of patients from minority diverse population. In the context of increasing migration, the identification of differences in access and drug use that may lead to health disparities is crucial. Based on a sequential mixed method study design, our objectives are to measure adherence to OAMs in two subgroups of non-migrants and migrants with various haematological malignancies, to identify the associated risk factors and to explore the representations that come into play with regards to illness and adherence behaviors. Essentially, the MADESIO protocol will contribute to assess whether and why patients with migrant backgrounds are a risk group regarding adherence to OAMs.

NCT ID: NCT04497701 Not yet recruiting - Lymphoma Clinical Trials

Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.

NCT ID: NCT04496375 Not yet recruiting - Solid Tumor Clinical Trials

An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application

ADN-CO
Start date: November 5, 2020
Phase:
Study type: Observational

The aim of our study is to investigate the effect of providing patients access to their electronic medical records Via the IPC Connect Application on their A Survey will be proposed to all outpatients with a solid or hematologic malignancy who will attend an appointement at Institut Paoli Calmettes clinic. Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31 questions addressed to all patients, 17 questions will be specifically addressed to patients using IPC connect application and 7 questions will be addressed to patients who do not use the application.

NCT ID: NCT04412135 Not yet recruiting - Hematologic Cancer Clinical Trials

The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality

SPIRIHEMATO
Start date: June 2020
Phase:
Study type: Observational

The management of patients with malignant hemopathy is based on comprehensive management. In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed

NCT ID: NCT04323605 Not yet recruiting - Clinical trials for Hematologic Neoplasms

Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant

AMA-ALLO
Start date: January 2021
Phase: N/A
Study type: Interventional

After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.

NCT ID: NCT02773342 Not yet recruiting - Clinical trials for Invasive Aspergillosis

An Evaluation of Sequential Computed Tomography of the Chest in Management of Invasive Pulmonal Aspergillosis in Neutropenic Patients With Haematological Malignancies

Start date: June 2013
Phase: N/A
Study type: Observational

The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in the last decade, the outcome of patients with IPA is still unsatisfactory and needs improvement. Particularly, recent developments in diagnostic imaging, including introduction of high-resolution computed tomography (CT) into standard procedures, made a place for improvement of diagnosis of IPA. Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis of pneumonia in febrile neutropenic patients and it is significantly superior to conventional chest X-ray. However, the method is associated with some difficulties mostly due to the broad spectrum of pathological findings in patients with IPA and their evolution over time. This has been described in retrospective studies on relatively small groups of patients. Prospective studies on larger populations are still missing, as well as studies on combination of different diagnostic modalities e.g. diagnostic imaging and microbiology. We recently published the results of the clinical trial: "A Phase II Dose Escalation Study of Caspofungin in Patients with Invasive Aspergillosis" which used caspofungin doses of 70 to 200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not reached, but response rates were impressive with complete plus partial responses accounting for 54.3% and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency towards higher doses yielding higher response rates. For the majority of these patients we obtained serial chest CT. So, for the first time a patient population is at hand, in which the kinetics of infiltrates over time can be described. The main objective is to describe the pathological findings in chest CT performed sequentially in IPA patients while receiving effective antifungal therapy. The specific objectives are: 1. Characteristics of pathological findings in sequential chest CTs - To describe the pathological findings (e.g. halo sign, air crescent sign and air consolidation) in sequential high resolution computed tomogrphy (HRCT) examinations - To calculate the incidence of individual pathological findings in sequential CT examinations - To calculate a total volume of fungal infiltrates in sequential CT examinations 2. Correlation of pathological findings in sequential CT with corresponding white blood count (WBC) and absolute neutrophil count (ANC) - To correlate the appearance or disappearance of individual pathological findings with WBC and ANC - To correlate the volume of fungal infiltrates in sequential CT examinations with WBC and absolute neutrophil count 3. Correlation of pathological findings in sequential CT with the serum galactomannan index - To correlate the appearance or disappearance of individual pathological findings with the serum galactomannan index - To correlate the volume of fungal infiltrates in sequential HRCT examinations with the serum galactomannan index 4. Correlation of pathological findings in sequential HRCT with outcome of IFI - To correlate the appearance or disappearance of individual pathological findings with outcome of IFI - To correlate the volume of fungal infiltrates in sequential HRCT examinations with outcome of IFI