This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. 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.
Study JZQB is a global research effort investigating a potential treatment for lung cancer. The study involves patients with a specific type of lung cancer that has certain genetic features. Researchers aim to compare the effectiveness of a new drug, LY3537982, when used in combination with pembrolizumab, against a placebo combined with pembrolizumab. The goal is to understand how well the new drug combination works in preventing the cancer from returning and whether it improves patients' overall quality of life. The study is carefully designed to align with real-world medical practices and will evaluate different doses of the new drug. It emphasizes safety, efficacy, and patient outcomes to provide valuable insights for future lung cancer treatments.
This study is for subjects that have been diagnosed with mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.
For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered proactively and free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment.
The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.
The purpose of this study is to test IMP1734 in humans for the first time and to assess the safety, tolerability, PK, PD, and anti-tumor activity of IMP1734 in patients with advanced solid tumors. The study will be conducted in 3 parts. Part 1 (dose escalation): Dose-escalation phase where the MTD (or MAD) will be
determined and safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMP1734. Part 2 (dose optimization): Further evaluation of the safety, tolerability, PK, PD, and preliminary anti-tumor activity of selected dose levels of IMP1734. Part 3 (dose expansion): Efficacy, safety, and PK of IMP1734 with the dose(s) selected based on accumulated data will be assessed in either patients who have not received prior therapy with a PARPi containing treatment.
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.
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.
In this study, all eligible study participants will have a clinically indicated reason to undergo a bronchoscopy procedure, using a EBUS-TBNA scope, before enrolling in the study. EBUS-TBNA stands for "endobronchial ultrasound-guided transbronchial needle aspiration" which is a procedure to collect lymph node tissue from within the lungs by inserting a flexible tube-like camera through the mouth, then down into the lungs.
After providing consent to participate in this study, each subject will be randomly assigned (by chance, like the flip of a coin) to either have or not have a cytopathology technologist (person who looks at samples under a microscope) in the room during your bronchoscopy, and then randomly assigned again (by chance, like the flip of a coin) to either have your tissue specimen prepared with clot or liquid preparation. Clot preparation is placing the tissue biopsy in a gel prior to being viewed under a microscope, whereas liquid preparation is placing the tissue biopsy in a liquid prior to being viewed under a microscope.
It is important to note that, by participating in this study, subjects will still receive the standard of care with a proven track record for obtaining lymph node tissue.
The reason for this research study is to determine whether rapid on-site cytopathologic evaluation, or the clot based method, can increase the chances of gathering adequate tissue for Next Generation Sequencing. Next generation sequencing is a test which detects molecular markers from tissue, or blood, samples and can provide possible treatment options for specific forms of lung cancer.