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NCT ID: NCT04332822 Recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

POLAR BEAR
Start date: August 19, 2020
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.

NCT ID: NCT04322318 Recruiting - Clinical trials for Stage III Kidney Wilms Tumor

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Start date: October 19, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

NCT ID: NCT04316013 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial

Start date: July 31, 2020
Phase: Phase 3
Study type: Interventional

VAPOR-C is a randomised study of the impact of IV versus inhaled anaesthesia (propofol versus sevoflurane) and lidocaine versus no lidocaine on duration of disease free survival inpatients with either colorectal or non small cell lung cancer.

NCT ID: NCT04310930 Recruiting - Clinical trials for Pulmonary Disease Due to Mycobacteria (Diagnosis)

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

FORMaT
Start date: March 2, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

NCT ID: NCT04291885 Recruiting - Clinical trials for Neuroendocrine Tumors

Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma

I-MAT
Start date: October 26, 2020
Phase: Phase 2
Study type: Interventional

The I-MAT trial is a randomised, placebo-controlled, phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.

NCT ID: NCT04277637 Recruiting - Clinical trials for Mature B-Cell Malignancies

Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

Start date: March 24, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

NCT ID: NCT04275726 Recruiting - Clinical trials for Aortic Valve Stenosis

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

LANDMARK
Start date: November 4, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

NCT ID: NCT04262466 Recruiting - Clinical trials for Select Advanced Solid Tumors

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Start date: February 25, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

NCT ID: NCT04204915 Recruiting - Aortic Stenosis Clinical Trials

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

EASY-AS
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Aortic stenosis (AS) affects approximately 5% of individuals >65 years old, with ~3% of people >75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.

NCT ID: NCT04073576 Recruiting - Type1diabetes Clinical Trials

Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

This is a study of the Minimed 670G 4.0 insulin pump, assessing the efficacy of the Advanced Hybrid Closed Loop (AHCL) algorithm in controlling blood glucose levels in Type 1 Diabetes.