This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.

This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.

This study is for patients diagnosed with unresectable locally recurrent or metastatic head and neck cancer. The purpose of this study is to test if adding an investigational drug called amivantamab to the usual chemotherapy (carboplatin and paclitaxel) is more effective in treating head and neck cancer when compared to being treated with carboplatin and paclitaxel alone. Carboplatin and paclitaxel are FDA approved to treat head and neck cancers; however, adding the study drug, amivantamab, is still being investigated and is not approved by the FDA.

Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 50 people taking part in this study, approximately 3 participants will be enrolled at MUSC.

Risks include constipation, nausea, rash, vomiting, swelling of arms and/or legs. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

This is a Phase 3 study. Phase 3 studies can involve testing a study drug in hundreds to thousands of people over several years. The main purpose of this study is to see if the study drug, Niraparib, works better than the comparator drug in people who have just been diagnosed with glioblastoma. The comparator drug is a type of chemotherapy commonly used to treat newly diagnosed glioblastoma.
This study includes:
• Phase 1, where subjects will take either the study drug or comparator drug. All participants will also receive radiotherapy in this phase. In this phase, there will be about 45 visits to the study center. The duration for this phase will last as long as the cancer does not get worse.
• Phase 2, where subjects will continue with the same drug given in Phase 1 without radiotherapy. In this phase there will be about 53 visits to the study center and participation in the study will last for 42 weeks.
There are four periods of the study, the screening period (last about 1 month), study treatment period (as long as desired or up to 8 months), safety follow-up period (1 month), and long-term follow up period (up to 5 years).
Some procedures in this study are blood tests, memory, speech and thinking test, ECG, tissue sample, bone marrow biopsy, and imaging test. Some risks include the cancer could get worse and there are risks associated with the study drugs (for example, low appetite, difficulty speaking, headaches, vomiting, nausea, diarrhea, etc.)

This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.

The purpose of this study is to compare the usual treatment alone to the usual treatment plus dose escalated radiation. This study seeks to find if this approach is better or worse than standard of care for locally advanced pancreatic cancer. Treatment and follow up for this study may be up to 8 years. The procedures include CT or MRI scans, chemotherapy, and radiation therapy. Risks include stomach pain, diarrhea, nausea, vomiting, tiredness, muscle aches, and weight loss. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

This study is for subjects who has been diagnosed with radioactive iodine refractory (RAIR) differentiated thyroid cancer. Subjects are expected to remain in the study for a minimum of 96 months. Drugs are FDA approved and is given in the form of Tablet to subjects. The procedures include urine protein test, CT, MRI. Risks include diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste, redness, pain or peeling of palms and soles, High blood pressure. There is evidence that dabrafenib, trametinib and cabozantinib are effective in stabilizing and shrinking the type of cancer, we do not know which of these approaches are better at prolonging time until tumor growth. However, information learned from the trial may help other people in the future.

This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. 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 phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.