Clinical Trials Using Decitabine

Clinical trials are research studies that involve people. The clinical trials on this list are studying Decitabine. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 36
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  • Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

    This screening and multi-sub-study Phase 1b / 2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
    Location: 17 locations

  • Azacitidine or Decitabine in Epigenetic Priming in Patients with Newly Diagnosed Acute Myeloid Leukemia

    This randomized phase II trial studies how well azacitidine or decitabine work in epigenetic priming in patients with newly diagnosed acute myeloid leukemia. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine or decitabine before usual chemotherapy may change the genetics of the leukemia cell by priming it to be more sensitive to the chemotherapy that will follow in treating patients with acute myeloid leukemia.
    Location: 13 locations

  • A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

    An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
    Location: 9 locations

  • An Open-Label, Multicenter, Phase 1b / 2 Study of the Safety and Efficacy of KRT-232 Combined With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

    This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed / refractory (having failed prior therapy) and will be assigned to receive KRT+232 with LDAC or KRT-232 with Decitabine.
    Location: 8 locations

  • Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd / 3rd / 4th Salvage

    Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed / refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg / m² / day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.
    Location: 8 locations

  • Epigenetic Reprogramming in Relapse / Refractory AML

    This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).
    Location: 8 locations

  • Ipilimumab and Decitabine in Treating Patients with Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia

    This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.
    Location: 9 locations

  • KRT-232 (AMG-232) and Decitabine in Treating Patients with Relapsed, Refractory, or Newly-Diagnosed Acute Myeloid Leukemia

    This phase Ib trial studies the side effects and best dose of murine double minute chromosome 2 (MDM2) inhibitor KRT-232 (AMG-232) when given together with decitabine in treating patients with acute myeloid leukemia that has come back (recurrent), does not respond to treatment (refractory), or is newly diagnosed. KRT-232 (AMG-232) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving KRT-232 (AMG-232) and decitabine together may work better than decitabine alone in treating patients with acute myeloid leukemia.
    Location: 7 locations

  • Pembrolizumab, Decitabine, and Standard Chemotherapy before Surgery in Treating Patients with Locally Advanced HER2-Negative Breast Cancer

    This phase II trial studies how well pembrolizumab and decitabine prior to standard chemotherapy before surgery changes the infiltration of lymphocytes into HER2-negative breast cancers that are large and / or have spread to lymph nodes. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Decitabine may increase the immune response to tumor cells by changing antigens on the tumor cells and by decreasing immunosuppressive cells in the tumor. Giving pembrolizumab and decitabine with chemotherapy may work better than chemotherapy alone in treating patients with HER2-negative breast cancer.
    Location: 4 locations

  • Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

    The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete hematologic recovery [CRi], Complete Remission with partial hematologic recovery [CRh], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory / relapsed AML.
    Location: 4 locations

  • GPS Compared With BAT in AML CR2 / CR2p

    To assess the safety and efficacy of galinpepimut-S compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second complete remission 2 (CR2) / second complete remission with incomplete platelet recovery (CR2p).
    Location: 6 locations

  • Ruxolitinib, Decitabine, and Donor Lymphocyte Infusion in Treating Patients with Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome after Stem Cell Transplant

    This phase II trial studies how well ruxolitinib, decitabine, and donor white blood cells (donor lymphocyte infusion [DLI]) work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back after a stem cell transplant. Patients who have relapsed after a stem cell transplant commonly receive an infusion of immune cells from the original donor called a DLI. A DLI uses high dose chemotherapy prior to the infusion which increases the risk of graft versus host disease, a condition in which the transplanted cells attack the recipient’s body. While the cancer responds temporarily to high dose chemotherapy alone, it hasn’t been shown to bring about long-term remission. Instead of high dose chemotherapy, this study pairs DLI with decitabine, another chemotherapy drug, and adds ruxolitinib. Ruxolitinib is a type of drug called a "JAK" inhibitor and may help prevent graft-versus host disease. Giving ruxolitinib with decitabine and a DLI may decrease the risk of graft-versus host disease and increase the chances of remission.
    Location: 4 locations

  • Dendritic Cell / AML Fusion Cell Vaccine with or without Decitabine in Treating Patients with Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant

    This phase I trial studies the side effects of dendritic cell / acute myeloid leukemia (AML) fusion cell vaccine with or without decitabine in treating patients with acute myeloid leukemia undergoing donor stem cell transplant. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving dendritic cell / AML fusion cell vaccine and decitabine may work better than dendritic cell / AML fusion cell vaccine alone in treating patients with acute myeloid leukemia.
    Location: 3 locations

  • ASTX727 for the Treatment of Advanced, Unresectable, or Metastatic Solid Tumors

    This phase I trial studies the side effects and best dose of ASTX727 for the treatment of solid tumors that have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced), cannot be removed by surgery (unresectable), or have spread to other places in the body (metastatic). ASTX727 is made up of two investigational drugs. One study drug is oral decitabine, which blocks abnormal cells or tumor cells from growing. The other study drug is called cedazuridine (E7727), which is a cytidine deaminase inhibitor, or CDAi. CDAi slows down how fast the oral decitabine disappears in the body.
    Location: 2 locations

  • Decitabine with Ruxolitinib or Fedratinib for the Treatment of Accelerated / Blast Phase Myeloproliferative Neoplasms

    This phase II trial studies how well decitabine with ruxolitinib or fedratinib works before hematopoietic stem cell transplant in treating patients with accelerated / blast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib and fedratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib or fedratinib, may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated / blast phase myeloproliferative neoplasms.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Donor Natural Killer Cell Therapy in Treating Patients with Recurrent or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

    This phase I trial studies the best dose of donor natural killer (NK) cell therapy and to see how well it works in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory), or myelodysplastic syndrome. Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body’s immune system and may interfere with the ability of cancer cells to grow and spread.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Decitabine, Venetoclax, and Ponatinib for the Treatment of Philadelphia Chromosome-Positive Acute Myeloid Leukemia or Myeloid Blast Phase or Accelerated Phase Chronic Myelogenous Leukemia

    This phase II trial studies how well the combination of decitabine, venetoclax, and ponatinib work for the treatment of Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia. Drugs used in chemotherapy such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine, venetoclax, and ponatinib may help to control Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia / Myeloproliferative Disease

    This phase II trial studies the side effects of salsalate when added to venetoclax and decitabine or azacitidine in treating patients with acute myeloid leukemia or myelodysplasia / myeloproliferative disease that has spread to other places in the body (advanced). Drugs used in chemotherapy, such as salsalate, venetoclax, decitabine, and azacitidine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

  • Pembrolizumab and Decitabine in Treating Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory

    This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find the best dose of pembrolizumab that can be safely given in combination with decitabine, and to determine what side effects are seen with this treatment.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Venetoclax in Combination with Decitabine for the Treatment of High-Risk Acute Myeloid Leukemia

    This phase I trial evaluates the best dose and side effects of venetoclax when given in combination with decitabine in treating patients with acute myeloid leukemia. Venetoclax may kill or stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell growth and survival. Decitabine belongs to a class of anti-cancer drugs known as DNA methyltransferase (DNMT) inhibitors, which change how diseased cells in the blood and bone marrow grow and multiply. Giving venetoclax in combination with decitabine may help treat patients with acute myeloid leukemia.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Quizartinib, Decitabine, and Venetoclax in Treating Patients with Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

    This phase I / II trial studies how well quizartinib, decitabine, and venetoclax work in treating patients with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving quizartinib, decitabine, and venetoclax may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Venetoclax and Decitabine in Treating Participants with Relapsed / Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

    This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML

    Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg / m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.
    Location: 2 locations

  • Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for, Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas

    Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the leading cause of cancer-related death in the United States. Most people with lung cancer are already in the advanced stages of the disease by the time they see a doctor. Researchers want to see if combining an approved drug with two new drugs can help. Objective: To study if tetrahydrouridine-decitabine (THU-DAC) with pembrolizumab is safe and effective in people with non-small cell lung cancer that cannot be removed by surgery. Eligibility: People 18 years and older who have NSCLC that cannot be removed by surgery Design: Participants will be screened with - Medical history - Physical exam - Blood and urine tests - Tests of heart and lung function They may have a small tumor sample taken (biopsy). They may have tumor scans. Before starting treatment, participants will repeat the screening tests. They will also give a stool sample. The study will be done in 3-week cycles for up to 6 cycles. - Participants will take the 2 study drugs by mouth 3-5 days a week. - Participants will get pembrolizumab in a vein for 30 minutes 1 day each cycle. Participants will keep a study medication diary. During cycle 1, participants will have blood taken multiple times on days 1 and 2. Every 3 cycles, participants will repeat screening tests. Participants will have a mandatory tumor biopsy. When they finish treatment, participants will have a physical exam and blood tests.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Cytarabine, Idarubicin and Liposome-encapsulated Daunorubicin-Cytarabine, or Venetoclax, Azacitidine, and Decitabine in Treating Older Patients with Acute Myeloid Leukemia

    This phase II trial studies how well cytarabine and idarubicin or venetoclax, azacitidine and decitabine work in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving patients cytarabine, idarubicin, liposome-encapsulated daunorubicin-cytarabine, venetoclax, azacitidine or decitabine may work better in treating patients with acute myeloid leukemia based on clinicogenetic risk stratification.
    Location: University of Nebraska Medical Center, Omaha, Nebraska


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