Mass General - Division of Clinical Research

The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations. Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.

Type: Observational

Start Date: May 2023

open study

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Type: Observational

Start Date: Sep 2024

open study

The goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.

Type: Interventional

Start Date: Dec 2023

open study

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.

Type: Interventional

Start Date: Jul 2023

open study

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Type: Interventional

Start Date: Dec 2022

open study

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.

Type: Interventional

Start Date: Sep 2022

open study

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Type: Interventional

Start Date: Oct 2022

open study

This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.

Type: Interventional

Start Date: Jun 2023

open study

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Type: Interventional

Start Date: Sep 2021

open study

The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.

Type: Observational

Start Date: Jan 2026

open study

The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g. ACE/CHIP and mosaicism).

Type: Observational [Patient Registry]

Start Date: Sep 2020

open study

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Type: Interventional

Start Date: Oct 2019

open study

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor. Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation. In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor. The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.

Type: Interventional

Start Date: Dec 2012

open study

The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.

Type: Interventional

Start Date: Mar 2026

open study

This is a mixed-methods study designed to develop and evaluate an innovative coaching program for physician trainee mothers. Approximately 48 participants will be recruited from informational flyers posted in resident work areas and distributed by program directors and GME. Interested participants will email study staff. Participants will be randomized to the control or intervention arm. Intervention participants will meet monthly with a novice physician coach of their choice (one-on-one) and a certified physician coach (with an assigned group of 6 peers through video-conferencing). Participants in both arms of the study will respond to surveys at three points: enrollment (baseline), 4 months, and 7 months. At each point, they will spend approximately 10 minutes filling the survey. The survey will query demographics, burnout, professional fulfillment, imposter phenomenon, self-valuation, self-efficacy, resilience, quality of life, and impact of work on professional relationships. The coaching intervention will last 4 months, and the 7 month survey will be used only to assess long-term effects of the intervention. At the conclusion of the study (7 months after enrollment), participants will be interviewed over video communication (secure Partners or Harvard Zoom) for approximately 30 minutes.

Type: Interventional

Start Date: Nov 2025

open study

This research study is an open-label Phase 1 Exploratory/Pilot clinical trial to measure the effects of the incretin mimetic, tirzepatide, on tissue, urine, blood, and microbiome biomarkers associated with colorectal cancer risk and to understand the feasibility of this precision prevention trial approach for a future larger study.

Type: Interventional

Start Date: Feb 2026

open study

This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).

Type: Interventional

Start Date: Dec 2025

open study

Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Type: Interventional

Start Date: Jul 2024

open study

Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

Type: Interventional

Start Date: Mar 2024

open study

The goal of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). The main question it aims to answer is: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to nine evidence-based therapies, will its adoption be associated with improved outcomes? Clinicians across five voice centers will be asked to use the RTSS-Voice to document their voice therapy sessions for patients with MTD. Researchers will compare changes in outcomes between two groups of patients: those treated during the clinician's first year using the RTSS-Voice versus those treated during the clinician's second year using the RTSS-Voice.

Type: Observational

Start Date: Feb 2026

open study

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

Type: Interventional

Start Date: Jun 2024

open study

The goal of this prospective cohort study is to assess potential differences in sleep biomarkers in older adult patients undergoing major orthopedic surgery. The main questions it aims to answer are: 1. To define sleep/circadian biomarkers of delirium (sleep duration, regularity, stability and timing of rhythm) in a prospective observational study. 2. To determine if plasma Alzheimer's disease (AD) pathology/inflammatory burden interacts with or moderates the relationship between a sleep/circadian biomarker and post-operative delirium (POD) risk. 3. To determine whether sleep/circadian regulation interacts with the genetic risk of AD to influence POD/cognitive decline. Participants will be asked to: 1. Donate several blood samples both intraoperatively and postoperatively 2. Complete baseline and postoperative neurocognitive assessments 3. Wear an actigraphy data collection watch for the two weeks prior to their surgery

Type: Observational

Start Date: Sep 2023

open study

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Type: Interventional

Start Date: Jul 2020

open study

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Type: Observational

Start Date: Apr 2018

open study