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.
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.
This study is for participants who have acute leukemia, a type of cancer of the blood and bone marrow. This study will help us learn more about a newly discovered oral drug, DSP-5336, that is being tested in people with acute leukemia and other types of blood cancer. DSP-5336 is a drug that interferes with a protein (Menin) in the body that has been found to have a role in developing leukemia. The main purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose that is safe for further study. The overall planned study duration, including the above visits and periods, is 50 months (4.2 years).
This study is for people newly diagnosed with acute myeloid leukemia (AML). An investigational (not approved by the FDA) drug, Tamibarotene, will be added to the standard of care drugs prescribed. Tamibarotene is a tablet that will be taken daily. The purpose of this study is to determine if the addition of this medication improves the prognosis of these subjects, as this is the first time it has been added to the treatment plan. The most common side effects observed to date include diarrhea, constipation, and vomiting, along with changes in the lab values. Procedures include lab work and bone marrow collections. Participation duration will depend upon how subjects respond to the treatment.
This project is being conducted in subjects that have been diagnosed with myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MPN) including chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who are candidates to receive treatment with single agent azacitidine based on local country approvals and/or local The study is designed to move efficiently from Phase 1 to Phase 3. This study is testing investigational drug called ASTX030. Investigational means that it is not approved by the Food and Drug Administration (FDA), but it is undergoing testing to find out if it is safe and effective. ASTX030 is a combination of two medicines, azacitidine and cedazuridine, given by mouth. The primary purpose is to test the levels of the investigational drug ASTX030 in your blood, including if food has an effect (Phase 1B only), the safety and tolerability of the drugs, and how subjects respond to the drug. The subject may remain in the study about 3 years. If you benefit from treatment, you may receive study drugs as long as you continue to benefit. If you develop side effects to the study drugs that prevent you from continuing treatment, or if your study doctor believes it is in your best interest to stop the study drug(s), you may be asked to stop the study treatment. After you stop treatment, the Sponsor will continue to collect health information to evaluate long-term effects of the study drugs.
This study is for patients who have newly diagnosed diagnosed BCR-ABL acute lymphoblastic leukemia (ALL). This study is being done to determine the effects (good or bad) of using the combination of a Tyrosine Kinase Inhibitor (TKI), steroids and blinatumomab versus treatment with steroids, Tyrosine Kinase Inhibitor (TKI) and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab.
This study is for subjects that have been diagnosed with AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome). This study is testing an "investigational" (not yet FDA approved) study drug called Sea-CD70. This study will find out if the drug is safe and tolerable, and find out the maximum tolerated dose (highest dose of a drug or treatment that does not cause unacceptable side effects) or recommended dose for the next phase of clinical study. The subject will be given the study drug in 28 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, ECG (electrocardiogram), or a bone marrow exam. The subject may remain in the study for up to approximately 3 years.
This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.