This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.
Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.
If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.
This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.
This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief skill building protocol and a mobile application. Participation involves three 60-90-minute skill building appointments during pregnancy, and four 30-minute check-in visits at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll. Compensation is provided.
The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.
Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.
Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.
An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.
In this study, researchers are testing a drug called Alisertib in people with a specific type of lung cancer that has spread extensively. These patients have already undergone the first round of treatment, but unfortunately, their cancer has started growing again. The drug alisertib works by targeting certain molecules involved in cell division, which are often overactive in cancer cells.
Patients will take alisertib as pills twice a day for a week, followed by a break. To manage side effects, they'll also receive another medication to support their blood cell production. Throughout the study, researchers will closely monitor how much alisertib is in the patients' blood and how they're responding to treatment.
The study will continue until patients either see their cancer progress, experience intolerable side effects, or decide to leave the study. Even if the cancer spreads to the brain during the study, patients might still be able to continue treatment if it's deemed helpful by their doctor. This research hopes to find out if alisertib can offer a new option for people whose lung cancer has come back after initial treatment.
This phase II/III study purpose is to see if neck and shoulder function and pain are better after sentinel lymph node (SLN) biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. If decided to participate in this study participants will go through a pre-treatment period to determine if they are eligible for the study including a PET/CT scan to determine if their cancer has spread. They will also receive a quality of life questionnaire to determine their physical well-being. Participants will complete these questionnaires 5 times: before surgery; at 3 weeks after surgery; and at 3, 6 and 12 months after surgery. If their cancer has not spread participants will be randomized to receive SLN or the SOC Elective Neck Dissection (END) to remove their cancer/lymph nodes during the treatment period. Following treatment, participants will enter the follow-up period and the study doctor will continue to follow participates condition and watch for side effects of the surgery. Participants will visit in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for their lifetime. The study duration for the phase II portion is about 37 months (~3.1 years) and around 132 months (11 years) for the phase III portion. The main risk associated with this study are leakage of lymph fluid called "chyle" into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.
This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.
This phase III study is for participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is negative for a type of virus called human papilloma virus (HPV). If decided to participate in this study, participants will be receive either ficlatuzumab in combination with cetuximab, or placebo in combination with cetuximab. There are 3 Arms participants will be randomly assigned to: Arm 1 will receive ficlatuzumab (10mg/kg by intravenous (IV) infusion) and cetuximab (by IV infusion), Arm 2 will be given ficlatuzumab (20mg/kg by IV infusion) and cetuximab, and Arm 3 will receive placebo and cetuximab. The effectiveness of the 2 different ficlatuzumab groups (Arm 1 and Arm 2) will be compared at the first on-study scan, and the more successful Arm will began enroll more participants. This study is estimated to last approximately 5 years. Study drugs will be administered until disease progression or unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). The main risk associate with the trial are swelling of your lower legs or arms, fatigue, shortness of breath, vomiting, diarrhea or constipation, bone pain, decreased appetite, anemia, high level of liver enzymes in your blood, dizziness, infusion reactions, cardiopulmonary arrest, pulmonary (lung) toxicity, skin reactions, inflammation of the mouth, low blood counts, liver problems, infection, headache, allergic reactions, and there may be unknown risks. This treatment can not guarantee the cancer will get better, since it may stay the same or get worse. What is discovered from this study may help other people in the future. The alternative to this study is not participating in this study and receiving HNSCC in patients who have previously received immunotherapy including chemotherapy with other treatment drugs or another clinical trial.
This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.
The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.
This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.