Clinical Trials Using Azacitidine

Clinical trials are research studies that involve people. The clinical trials on this list are studying Azacitidine. 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 82
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  • Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

    The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate / high / very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
    Location: 31 locations

  • Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

    The primary objectives of this study are: - To confirm the safety and tolerability of magrolimab monotherapy in a relapsed / refractory (R / R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R / R AML and MDS - To evaluate the efficacy of magrolimab monotherapy in R / R AML / MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML / MDS, or R / R AML / MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS - To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate
    Location: 21 locations

  • Nivolumab with or without Azacitidine in Treating Patients with Recurrent Resectable Osteosarcoma

    This phase I / II trial studies the best dose and side effects of azacitidine and how well it works with or without nivolumab in treating patients with osteosarcoma that has come back (recurrent) and can be removed by surgery (resectable). 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 azacitidine, 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 nivolumab and azacitidine together may work better compared to nivolumab alone in treating patients with osteosarcoma.
    Location: 16 locations

  • 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

  • BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia

    This phase II trial studies how well azacitidine and venetoclax chemotherapy with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine 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. 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 azacitidine and venetoclax chemotherapy with pembrolizumab may increase the rate of deeper / better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.
    Location: 13 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

  • IMGN632 as Monotherapy or With Venetoclax and / or Azacitidine for Patients With CD123-Positive Acute Myeloid Leukemia

    This is an open-label, multicenter, Phase 1b / 2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and / or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.
    Location: 12 locations

  • Nivolumab in Combination With 5-azacytidine in Childhood Relapsed / Refractory AML

    This is a phase I / II Study of Nivolumab in Combination with 5-azacytidine in pediatric patients with relapsed / refractory acute myeloid leukemia
    Location: 16 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

  • Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

    This Phase 1 / 2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML / MDS disease states.
    Location: 13 locations

  • Triple Combination of Pevonedistat and Venetoclax Plus Azacitidine in Adults With Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

    The purpose of this study is to determine whether the combination of pevonedistat + venetoclax + azacitidine improves event-free survival (EFS) compared with venetoclax + azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy.
    Location: 9 locations

  • APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

    This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.
    Location: 8 locations

  • Azacitidine, Entinostat, and Nivolumab or Nivolumab Alone in Treating Patients with Recurrent Metastatic Non-small Cell Lung Cancer

    This phase II trial studies how well azacitidine, entinostat, and nivolumab or nivolumab alone work in treating patients with non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as azacitidine, 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. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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.. It is not yet known if azacitidine and entinostat followed by nivolumab or nivolumab alone is more effective in treating non-small cell lung cancer.
    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

  • Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

    Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 200 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
    Location: 7 locations

  • Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

    The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
    Location: 6 locations

  • AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

    At least one dose level of AMG 176 will achieve acceptable safety and tolerability in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia
    Location: 6 locations

  • A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

    CC-90009-AML-002 is an exploratory Phase 1b open-label multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in subjects with acute myeloid leukemia (AML).
    Location: 6 locations

  • A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

    Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 tablet to SC azacitidine. The duration of the study is expected to be approximately 36 months.
    Location: 5 locations

  • Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

    This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in combination with 5-Azacitidine which will be composed of a dose escalation phase followed by dose expansion cohort of GSK3326595.
    Location: 5 locations

  • Pevonedistat and Azacitidine in Treating Patients with Refractory or Relapsed Myelodysplastic Syndrome or Myelodysplastic Syndrome / Myeloproliferative Neoplasm Who Fail Primary Therapy

    This phase II trial studies how well pevonedistat and azacitidine work in treating patients with myelodysplastic syndrome or myelodysplastic syndrome / myeloproliferative neoplasm that has failed primary therapy, that does not respond to treatment (refractory), or has come back (recurrent). Pevonedistat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

    This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment with intensive chemotherapy.
    Location: 5 locations

  • A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival

    The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month. Part 3 will be the Dose Finding portion to determine levels of venetoclax in combination with Azacitidine (CC-486) to be explored. CC-486, and BSC may be administered for up to 24 cycles.
    Location: 5 locations

  • Azacitidine and Enasidenib in Treating Patients with IDH2-Mutant Myelodysplastic Syndrome

    This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations

  • Tagraxofusp-erzs, Azacitidine and Venetoclax for the Treatment of Untreated, Relapsed, or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

    This phase I trial studies the side effects and best dose of tagraxofusp-erzs (SL-401) when given together with azacitidine, or azacitidine and venetoclax, in treating patients with acute myeloid leukemia that is untreated, has come back (relapsed), or does not respond to treatment (refractory) or myelodysplastic syndrome. Combinations of biological substances in tagraxofusp-erzs may be able to carry cancer-killing substances directly to cancer cells. Drugs used in chemotherapy, such as 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. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Giving tagraxofusp-erzs with azacitidine and venetoclax may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome compared to standard therapy.
    Location: 4 locations


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