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 46
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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

  • 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: 16 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: 12 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 in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.
    Location: 10 locations

  • Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

    The purpose of the phase 1b / 2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed / refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy, or who have received one prior treatment for their AML.
    Location: 8 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

  • 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: 8 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: 5 locations

  • A Phase 1b / 2 Study of Alvocidib Plus Decitabine in Patients With MDS

    Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used in patients with AML. Eight Phase I or II clinical trials have been completed in patients with AML, totaling more than 400 patients with both relapsed / refractory or newly diagnosed AML. Preclinical studies have demonstrated that decitabine exposure increased the expression of NOXA, which is a specific antagonist of the survival factor MCL 1. Pharmacologic downregulation of MCL-1 via CDK 9 inhibition, as well as upregulation of the MCL-1 antagonist, NOXA, following decitabine exposure may result in enhanced antileukemic activity in MCL-1-dependent malignancies.
    Location: 4 locations

  • 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: 5 locations

  • Pembrolizumab with Decitabine and / or Pralatrexate in Treating Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma or Cutaneous T-Cell Lymphoma

    This phase Ib trial studies the side effects and best dose of decitabine and pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma that have come back or do not respond to treatment. Drugs used in chemotherapy, such as pralatrexate 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. 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. Giving pembrolizumab with decitabine and / or pralatrexate may work better in treating patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma.
    Location: 4 locations

  • Clinical Trial of BP1001(Liposomal Grb2 Antisense Oligonucleotide) in Combination With Decitabine in AML / High Risk MDS

    The primary objective of this study is to assess whether the combination of BP1001 and decitabine provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete hematologic recovery [CRi], Complete Remission with partial hematologic recovery [CRh], than decitabine alone (by historical comparison) in participants with AML / High Risk MDS that cannot or elect not to be treated with more intensive chemotherapy. The historical comparison to be used will be defined in the Statistical Analysis Plan (SAP) prior to database closure.
    Location: 4 locations

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

    Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed / refractory after 2 or 3 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) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.
    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

  • Study of PDR001 and / or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

    To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and / or MBG453 in combination with decitabine in AML and high risk MDS patients, and to identify recommended doses for future studies.
    Location: 3 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: 5 locations

  • Testing Nivolumab in Combination with Decitabine and Venetoclax in Patients with Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia

    This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as nivolumab, 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 and venetoclax, 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 study is being done to find out whether giving nivolumab, decitabine, and venetoclax is better or worse than the usual approach for TP53-mutated acute myeloid leukemia.
    Location: 2 locations

  • Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN, AML, and hrMDS.

    A phase 1 / 2 study to assess the safety and efficacy of MB-102 in patients with relapsed or refractory BPDCN, AML or high-risk MDS.
    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 and Talazoparib in Treating Patients with Untreated Relapsed, or Refractory Acute Myeloid Leukemia

    This phase I / II trial studies best dose and side effects of decitabine and talazoparib and how well they work in treating patients with acute myeloid leukemia that is untreated, has come back, or does not respond to treatment. Decitabine and talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    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

  • 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: 3 locations

  • Glasdegib and Decitabine for the Treatment of Poor-Risk Acute Myeloid Leukemia in Patients Who Are Unfit or Refuse Intensive Chemotherapy, GLAD-AML Study

    This phase II trial studies how well glasdegib and decitabine work in treating patients with poor-risk acute myeloid leukemia (AML) who are unfit for or refuse intensive chemotherapy. Glasdegib is an oral medication which works by preventing the growth of cells that are thought to become AML cells. This may also help drugs like decitabine work better. 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 glasdegib together with decitabine may increase the rate of remission observed with the current standard of care.
    Location: Yale University, New Haven, Connecticut

  • Quizartinib, Decitabine, and Venetoclax in Treating Participants 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 participants 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 and venetoclax, 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 quizartinib and decitabine 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


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