Depression is common among cancer survivors but current screening approaches are not adequate. To help develop better strategies to screen for depression among cancer survivors, we will conduct a pilot randomized controlled trial with cancer survivors to evaluate whether a text message based approach to depression screening is feasible, acceptable, and potentially more effective than existing standard of care approaches to depression screening among cancer survivors.
This study is for patients scheduled for a bronchoscopy, a procedure that allows doctors to examine lungs and airways for evaluation of suspicious lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups based on the Rapid On Site Evaluation of the initial sample obtained by the doctor performing the bronchoscopy as part of the standard of care procedure for the patient. the potential groups the subject will be randomized into are: Cryoprobe or transbronchial biopsy needle. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. 7 days following the procedure, a member of the study team will check the subjects medical chart to assess whether any adverse events have occurred.
This study is for patients that have been diagnosed with high risk neuroblastoma. This study is testing an investigational drug called Dinutuximab, which will be combined with standard care induction and transplant. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
The primary purpose of this study is to compare treatment outcomes of participants who are assigned to early chemoimmunotherapy (Dinutuximab and Sargramostim) during Induction to treatment outcomes of participants who are not assigned to treatment that includes early chemoimmunotherapy. Participants will be randomized to the standard of care arm of the trial or the standard of care arm plus chemoimmunotherapy (like flipping a coin). The investigational drug is given to participants through IV infusion. Participants in this study can expect to be in this study for a total of five years.
This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.
This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
This study is for patients that have recurrent/persistent endometrial cancer. The investigational drug used in this study is Sacituzumab Govitecan (SG). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The study drug is given to participants through infusion. The primary purpose of the study is to compare the effect of SG relative to treatment of physician's choice (TPC) on progression-free survival (PFS) and on overall survival (OS). Participants can expect to be on this study until their demise.
This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.
The purpose of this study is to see if the investigational study drug, called cusatuzumab, is safe and effective when given together with other standard of care drugs used to treat Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow. Cusatuzumab is a new type of drug for AML. Cusatuzumab is designed to target a protein found on the surface of AML tumor cells, called human cluster of differentiation CD70. CD70 is not widely found in healthy cells. By targeting and killing cells expressing CD70, cusatuzumab has been shown in the laboratory and in animal studies to reduce tumor growth. In this study, cusatuzumab is being tested together with two other drugs that are commonly used to treat AML as a standard of care. These standard of care drugs are called venetoclax and azacitidine. In this consent form, cusatuzumab, venetoclax, and azacitidine will be referred to as "study drugs".
This study is for subjects that have been diagnosed with cancer in their
arm, leg, or trunk (the part of the body that involves the chest, abdomen,
and pelvis). The purpose of this research study is to preserve healthy
tissue around the cancer on the arm(s) and/or leg(s) using
hypofractionated radiotherapy, while treating the cancer and preventing
it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.