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NCT ID: NCT05578976 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

EPCORE DLBCL-2
Start date: February 8, 2023
Phase: Phase 3
Study type: Interventional

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05577715 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

Start date: November 14, 2022
Phase: Phase 2
Study type: Interventional

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

NCT ID: NCT05577416 Recruiting - Glioma Clinical Trials

A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma

AB-218-IIT-201
Start date: October 11, 2022
Phase: Early Phase 1
Study type: Interventional

The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection.

NCT ID: NCT05574010 Recruiting - Celiac Disease Clinical Trials

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

Start date: November 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

NCT ID: NCT05573984 Recruiting - Clinical trials for Retinitis Pigmentosa

Natural History of PRPF31 Mutation-Associated Retinal Dystrophy

Start date: July 7, 2022
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history through temporal systemic evaluation of subjects identified with PRPF31 mutation-associated retinal dystrophy, also called retinitis pigmentosa type 11, or RP11. Assessments will be completed to measure and evaluate structural and functional visual changes including those impacting patient quality of life associated with this inherited retinal condition and observing how these changes evolve over time.

NCT ID: NCT05572515 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-9
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

NCT ID: NCT05572073 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Otoferlin Gene-mediated Hearing Loss Natural History Study

Start date: July 14, 2022
Phase:
Study type: Observational

This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.

NCT ID: NCT05570591 Recruiting - Clinical trials for Central Serous Chorioretinopathy

Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy

NANO-C
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multicentre, sham-controlled, participant- and assessor-masked superiority trial with two parallel treatment arms which aims to investigate the safety and efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid secondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomical outcomes. The study population will be individuals with adults (aged 18-70 years inclusive) with non-resolving CSCR (defined as CSCR present for a duration of more than 3 months presenting with either focal or diffuse leakage) who meet all eligibility criteria. 60 subjects total will be enrolled into the study - 40 randomized to receive SNL treatment and 20 to receive sham treatment as per a 2:1 randomization schedule and stratified by type of CSCR (focal vs diffuse). The study has a 24-week study period with five scheduled visits: screening, randomisation (first treatment), 6-week follow up (with second treatment where eligible), 12-week follow-up , 18-week follow-up, and 24-week follow-up. The primary outcome is the proportion of laser-treated study eyes that show resolution of sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) compared to sham-treated study eyes at 24 weeks. The safety endpoint will be proportion of laser-treated eyes that lose ≥10 letters of of vision (measured on a standard vision chart) compared to sham-treated study eyes and fellow eyes over 24 weeks.

NCT ID: NCT05570227 Recruiting - Melanoma Clinical Trials

Metabolic Phenotypes in Melanoma

MetaMel
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.

NCT ID: NCT05568888 Recruiting - Traumatic Injury Clinical Trials

Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

Start date: March 28, 2023
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.