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NCT ID: NCT04401995 Active, not recruiting - Melanoma Clinical Trials

Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab

Start date: September 2, 2020
Phase: Phase 2
Study type: Interventional

The main goal of this research study is to determine how nivolumab and nivolumab/Vidutolimod (CMP-001) combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas. The main goal of the PET/CT scan with 18F]F-AraG is to evaluate how [18F]F-AraG uptake changes before and after administration of either nivolumab or nivolumab/CMP-001 combination.

NCT ID: NCT04401943 Active, not recruiting - Systemic Sclerosis Clinical Trials

Online Fatigue Intervention Program for People With Scleroderma

FAME-ISS
Start date: May 13, 2020
Phase: N/A
Study type: Interventional

This research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. This study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time.

NCT ID: NCT04401774 Active, not recruiting - Clinical trials for Primary Central Nervous System Lymphoma (PCNSL)

Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy

Start date: May 22, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this additional part of the study is to test whether the study drug, nivolumab, is a safe treatment that will prevent participants' primary central nervous system lymphoma (PCNSL) from growing again (recurrence). Participants will be people with PCNSL who continue to have cell free tumor DNA (cfDNA) in their CSF despite completion of their first treatment (first-line treatment).

NCT ID: NCT04401748 Active, not recruiting - Clinical trials for Myelodysplastic Syndrome (MDS)

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

Verona
Start date: September 10, 2020
Phase: Phase 3
Study type: Interventional

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

NCT ID: NCT04401267 Active, not recruiting - Hypertension Clinical Trials

Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma

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

This is a randomized unblinded Phase II clinical trial evaluating the impact of intensive antihypertensive control (targeted to the 50-75th percentile for age, sex, and height) compared to conventional antihypertensive control (targeted to the 90-95th percentile for age, sex, and height) on the incidence of radiographically extensive osteonecrosis in children and young adults receiving treatment for newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL). Primary Objective - Compare the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy. Secondary Objectives - Evaluate the efficacy of intensive antihypertensive control compared to conventional antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or higher) and radiologically extensive osteonecrosis, overall and stratified by joints. - Compare the frequency of clinically significant and radiographically extensive osteonecrosis in patients receiving antihypertensive therapy and historical controls. - Compare blood pressures achieved in intensive and conventional arms using both pressures obtained as part of routine patient care and ambulatory blood pressure monitoring. - Compare levels of vascular dysfunction as measured physiologically, radiographically, and in blood samples in patients receiving intensive compared to standard antihypertensive therapy. Exploratory Objectives - Identify predictive patterns of blood biomarkers which identify patients at high- risk of developing clinically significant osteonecrosis. - Identify MRI findings during late induction which correlate with osteonecrosis lesions seen during reinduction. - Identify patterns of diurnal blood pressure variation as measured by ambulatory blood pressure monitoring associated with the later development of osteonecrosis. - Compare induction blood pressure control and intervention arm to echocardiographic changes at reinduction II. - Evaluate patient-reported, health-related quality of life in patients during induction and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.

NCT ID: NCT04401020 Active, not recruiting - Neoplasm Malignant Clinical Trials

First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

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

Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D) Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To assess preliminary evidence of antitumor activity

NCT ID: NCT04400331 Active, not recruiting - Chorea, Huntington Clinical Trials

Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

Start date: September 18, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.

NCT ID: NCT04398524 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Oropharynx

A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

NCT ID: NCT04398485 Active, not recruiting - Clinical trials for Refractory Multiple Myeloma

A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma

Start date: January 20, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.

NCT ID: NCT04398446 Active, not recruiting - Breast Cancer Clinical Trials

Effect of Hemp-CBD on Patients With CIPN

Coala-T-CBD
Start date: May 27, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.