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NCT ID: NCT04504825 Active, not recruiting - AL Amyloidosis Clinical Trials

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis

Start date: February 2, 2021
Phase: Phase 3
Study type: Interventional

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

NCT ID: NCT04504669 Active, not recruiting - Melanoma Clinical Trials

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

NCT ID: NCT04502446 Active, not recruiting - T Cell Lymphoma Clinical Trials

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

Start date: July 31, 2020
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

NCT ID: NCT04501484 Active, not recruiting - Essential Tremor Clinical Trials

Bilateral Essential Tremor Treatment With FUS

BEST-FUS
Start date: July 8, 2020
Phase: N/A
Study type: Interventional

Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 1 and 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.

NCT ID: NCT04499924 Active, not recruiting - Clinical trials for Gastric Adenocarcinoma

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

MOUNTAINEER-02
Start date: March 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.

NCT ID: NCT04499690 Active, not recruiting - Depression Clinical Trials

Global CALM Implementation Study

Global CALM
Start date: June 17, 2019
Phase:
Study type: Observational

This study seeks to evaluate the implementation of the Managing Cancer and Living Meaningfully (CALM) Program in diverse cultural settings, including its feasibility, fidelity, and acceptability. It will also assess the cross-cultural generalizability of the CALM intervention with a particular focus on patient-reported outcomes with regard to psychological well-being and quality of life.

NCT ID: NCT04498117 Active, not recruiting - Ovarian Cancer Clinical Trials

Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

FLORA-5
Start date: August 25, 2020
Phase: Phase 3
Study type: Interventional

Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.

NCT ID: NCT04497844 Active, not recruiting - Clinical trials for Metastatic Castration-sensitive Prostate Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

AMPLITUDE
Start date: September 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

NCT ID: NCT04495556 Active, not recruiting - Multiple Sclerosis Clinical Trials

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

CAVS-MS
Start date: September 11, 2020
Phase:
Study type: Observational

The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.

NCT ID: NCT04494425 Active, not recruiting - Clinical trials for Advanced or Metastatic Breast Cancer

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

DB-06
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.