Boston University - Clinical & Translational Science Institute

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Type: Interventional

Start Date: Jan 2025

open study

Transthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque- like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely.

Type: Interventional

Start Date: May 2025

open study

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.

Type: Interventional

Start Date: Oct 2024

open study

This investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population. The study aims are to: 1. evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and 2. ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation. Participants will be contacted by the PN and provided with a survey instrument that will test their medical literacy. Then the PN will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. These tasks are part of pursuing fertility care at BMC. Duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have PN services will be utilized as a comparison group. Regression analyses will be conducted to explore the association between utilization of a PN and pregnancy rates, considering potential confounding factors. Establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. Strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. By tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.

Type: Interventional

Start Date: Feb 2025

open study

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

Type: Interventional

Start Date: Nov 2024

open study

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Type: Interventional

Start Date: Aug 2024

open study

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Type: Interventional

Start Date: Jul 2024

open study

This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries. The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time. A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives: 1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications 2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.

Type: Interventional

Start Date: Jan 2024

open study

The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is: • Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either: - Receive care as usual (CSC) or - Receive care as usual (CSC) plus five additional care elements (CSC 2.0): 1. Individual peer support 2. Digital outreach 3. Care coordination 4. Multi-family group therapy 5. Cognitive remediation Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.

Type: Interventional

Start Date: Feb 2024

open study

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

Type: Interventional

Start Date: Oct 2023

open study

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Type: Interventional

Start Date: Feb 2024

open study

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

Type: Interventional

Start Date: Jun 2023

open study

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

Type: Interventional

Start Date: Mar 2023

open study

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Type: Interventional

Start Date: Jan 2023

open study

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

Type: Interventional

Start Date: Oct 2023

open study

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Type: Interventional

Start Date: Nov 2022

open study

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.

Type: Interventional

Start Date: Mar 2022

open study

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Type: Interventional

Start Date: Dec 2021

open study

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age.

Type: Interventional

Start Date: Dec 2020

open study

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Type: Interventional

Start Date: Jan 2020

open study

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently a very imprecise, subjective method that varies amongst different doctors for the same patient is used to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). A previous plot study was conducted by the investigators to determine if spatial frequency domain imaging (SFDI), a method of light scattering, could be used to measure the collagen content in the skin of SSc patients. This non-painful, noninvasive method takes very little time and the investigators hypothesized that it would be more accurate than the "pinching" method. For that pilot study, patients with various stages of the disease were selected, and SFDI was used to image 6 areas. A forearm skin biopsy was taken for subsequent histopathology analyses of collagen content. The clinical mRSS was assessed at the time of SFDI measurement. Optical property imaging data was analyzed and statistically correlated and analyzed with immunohistochemistry (a method of identifying proteins) of the skin. Preliminary results demonstrated a strong correlation between mRSS and SFDI. Some of the imaging parameters of the SFDI were modified based on the initial results. Initial results demonstrated that the device can detect increases in skin thickness observed in SSc skin.

Type: Interventional

Start Date: Nov 2025

open study

Hospital discharge is a dangerous time for patients: one in five will suffer an adverse event, such as a medication error, and nearly 25% will be readmitted within 30 days. This time is even more dangerous for patients with who face communication barriers, including those with non-English language preference (NELP), low health literacy, and the elderly. The investigators will pilot a post-discharge educational intervention to reinforce written discharge instructions (known as the After Visit Summary or AVS) using a randomized controlled trial design (2:1 intervention: control). The control group will receive current standard of care discharge education which includes a nurse reviewing their AVS and an automated call in English that allows patients to numerically select types of problems/questions that are then escalated to a nurse who should return their call within a few days. The intervention group will receive the standard of care discharge education with the AVS and an additional post-discharge educational call delivered by a registered nurse or other qualified health professional with the option to have written instructions professionally translated and sent via MyChart message--if available in their preferred language.

Type: Interventional

Start Date: Jan 2026

open study

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC). A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.

Type: Interventional

Start Date: Feb 2026

open study

Given the thicker cortical bone in the mandible compared to the maxilla, mandibular teeth cannot be effectively anesthetized via local infiltration anesthesia. Instead, clinicians typically perform regional anesthesia and most commonly, Inferior Alveolar Nerve block (IANB). However, the inferior alveolar nerve is deeply submerged by surrounding structures of bone, muscles, ligaments and vessels. Traditional IANB is a technique by using anatomical landmarks not directly related to Inferior Alveolar Nerve (IAN) to approximate the location of mandibular foramen, where IAN enters mandible. IANB is considered a blind technique and known for the lack of accuracy and precision. The failure rate can be as high as 30-45%. In contrast, the investigator's cone beam computed tomography (CBCT) guided IANB device (IANBD) effectively directs the needle to the mandibular foramen which improves the success rate of the IANB on the first attempt, minimizes injection tissue damage, and reduces patient discomfort. In this proof of concept trial, a 3D printed CBCT guided IANBD will be used to administer anesthesia at three injection sites instead of the traditional IANB technique. Participants will be consented patients at the postdoctoral endodontic treatment center, Department of Endodontics, Boston University (BU) Henry M. Goldman School of Dentistry. The goal of this research is to to evaluate the acceptability, safety, and effectiveness of guided anesthesia using the IANBD by enrolling 10 subjects who require non-surgical endodontic therapy with a simple, affordable and reliable prototype to be used by clinicians in the dental care setting.

Type: Interventional

Start Date: Dec 2025

open study

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Type: Interventional

Start Date: Dec 2024

open study