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NCT ID: NCT04623541 Recruiting - Clinical trials for Small Lymphocytic Lymphoma

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

EPCORE™ CLL-1
Start date: November 25, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.

NCT ID: NCT04623476 Recruiting - Crohn Disease Clinical Trials

PAtophysiological, Nodal-based Approach for Crohn's Disease Excision

PANACEAPILOT
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence. The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence. Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease). Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.

NCT ID: NCT04623216 Recruiting - Clinical trials for Acute Myeloid Leukemia

Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with AML/secondary AML who are in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (MRD+ post-aHSCT), can enhance the graft versus leukemia (GvL) response and prevent or delay hematologic relapse without an unacceptable level of treatment-emergent toxicities, including clinically significant acute and/or chronic graft-versus-host disease (GvHD) and immune-related adverse events

NCT ID: NCT04622826 Recruiting - Covid-19 Pneumonia Clinical Trials

plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients

Start date: May 15, 2020
Phase: Phase 2
Study type: Interventional

Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms. Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.

NCT ID: NCT04622644 Recruiting - Stroke, Ischemic Clinical Trials

Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes

Start date: February 23, 2021
Phase: N/A
Study type: Interventional

This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.

NCT ID: NCT04622423 Recruiting - Liver Metastasis Clinical Trials

Advanced Therapies for Liver Metastases

LiMeT
Start date: November 6, 2019
Phase:
Study type: Observational

Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies. Based on preliminary and published data, the investigators hypothesize that innovative immune, gene and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC. The investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, metastatic and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and/or liver metastases as well as correlate changes in the activation status and phenotype of peripheral blood leukocytes. Healthy volunteers will be enrolled as negative controls. The investigators aim at identifying: i) actionable tumor associated antigens (TAAs) and local immune suppressive and regulatory pathways; ii) biological parameters for early diagnosis of relapse; iii) the effect of therapies on the shaping of anti-tumor immune responses. Data collected will be instrumental for the generation of novel advanced therapy medicinal products (ATMPs). Indeed, this protocol is part of a multi-partner translational program, supported by the AIRC 5 per Mille 2019 grant, focused on the development, validation and implementation for clinical testing of ATMPs to ameliorate the cure of CRC and PDAC and possibly help the study of other solid tumors. Moreover, the systematic and long-term follow-up of enrolled patients will possibly point at early predictors of differential prognosis and patients' categories eligible for tailored therapies, including those with the novel ATMPs.

NCT ID: NCT04621851 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation

Start date: September 30, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.

NCT ID: NCT04621201 Recruiting - Clinical trials for Diagnosed or Relapsed/Refractory Sarcomas

Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

Start date: December 6, 2018
Phase:
Study type: Observational

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.

NCT ID: NCT04620980 Recruiting - Parkinson Disease Clinical Trials

Assessing the Polygenic Burden of Rare Disruptive Mutations in Parkinson's Disease

Start date: June 15, 2021
Phase:
Study type: Observational [Patient Registry]

The project intends to assess the polygenic burden of rare disruptive mutations in Parkinson's disease (PD) and how they influence the phenotype/pathological heterogeneity of disease.

NCT ID: NCT04620239 Recruiting - Clinical trials for Transitional Cell Cancer of Renal Pelvis and Ureter

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

UCM301
Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment