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 39
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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.
    Location: 13 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: 14 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, or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose or recommended phase 2 dose of Onvansertib in combination with decitabine or and Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, one regimen (either Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine) 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

  • MDM2 Inhibitor 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 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. MDM2 inhibitor 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 MDM2 inhibitor AMG-232 and decitabine together may work better than decitabine alone in treating patients with acute myeloid leukemia.
    Location: 11 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: 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: 8 locations

  • Low Dose Decitabine, Low Dose Azacitidine, or Standard Dose Azacitidine in Treating Patients with Transfusion-Dependent Myelodysplastic Syndrome or Best Supportive Care in Patients with Transfusion-Independent Myelodysplastic Syndrome

    This randomized phase II trial studies how well low dose decitabine, low dose azacitidine, or standard dose azacitidine works in treating patients with myelodysplastic syndrome (MDS) who need blood transfusion (transfusion-dependent) compared to best supportive care in patients with MDS who do not need blood transfusion (transfusion-independent). Drugs used in chemotherapy, such as 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. It is not yet known whether low dose decitabine, low dose azacitidine, or standard dose azacitidine is most effective in treating or offering best supportive care for patients with myelodysplastic syndrome.
    Location: 6 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

  • 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: 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 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: 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

  • Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

    Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
    Location: 2 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 (cedazuridine and decitabine) 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 cancer 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

  • 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

  • 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. 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

  • DEC-205 / NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia

    This phase I trial studies the side effects of DEC-205 / NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205 / NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the immune system in different ways and stop cancer cells from growing. 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. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving DEC-205 / NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • The Immune Checkpoint Inhibitor Pembrolizumab in Combination With Oral Decitabine and Tetrahydrouridine as First-Line Therapy for Inoperable, Locally Advanced or Metastatic Non-small Cell Lung Cancer

    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

  • Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients with Recurrent or Refractory Leukemia

    This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that does not respond to previous treatment (refractory). Palbociclib, sorafenib, and decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, 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. Giving palbociclib alone and in combination with sorafenib, decitabine, or dexamethasone may work better in treating patients with recurrent or refractory leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Decitabine in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

    This phase II trial studies how well decitabine works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Genetically Modified T Cells and Decitabine in Treating Patients with Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    This phase I trial studies the side effects of genetically modified T cells and decitabine in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) or has not responded to previous treatments (refractory). White blood cells called T cells are collected via a process called leukapheresis, genetically modified to recognize and attack tumor cells, then given back to the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically modified T cells and decitabine may kill more tumor cells.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • Pevonedistat and Decitabine in Treating Patients with High Risk Acute Myeloid Leukemia

    This phase I trial studies the side effects and best dose of pevonedistat when given together with decitabine in treating patients with high risk acute myeloid leukemia. Pevonedistat and decitabine may stop the growth of cancer cells by blocking some of the enzymes need for cell growth.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California


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