Treatment Clinical Trials for Adult Acute Myeloid Leukemia

Clinical trials are research studies that involve people. The clinical trials on this list are for adult acute myeloid leukemia treatment. 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 29
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  • Study of Iomab-B Prior to Hematopoietic Cell Transplant vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

    The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).
    Location: 12 locations

  • Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

    The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and / or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
    Location: 10 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

  • Study of IMGN632 in Patients With Relapse / Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies

    This is an open-label, multi-center, Phase 1 / 2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease. The study is currently enrolling eligible AML, BPDCN and ALL patients.
    Location: 7 locations

  • Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R / R FLT3 Mutated AML

    This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed / refractory AML subjects with FLT3 activating mutation.
    Location: 7 locations

  • Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

    A Phase 1 / 2a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia to determine the safety, tolerability, PK and preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2a will consist of up to 3 dose levels (high, medium, and low) of which subjects with FLT3 mutations will randomly be assigned.
    Location: 7 locations

  • A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

    CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory high-risk myelodysplastic syndrome.
    Location: 5 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

  • Donor-Derived Tumor-Associated Antigen-Specific T Cells in Treating Participants with Relapsed or Refractory acute myeloid leukemia or myelodysplastic syndrome

    This phase I trial studies the best dose and how well donor-derived multi-tumor-associated antigen specific T cells work in treating participants with acute myeloid leukemia or myelodysplastic syndrome that have come back or does not respond. Tumor associated antigen-specific T cells are immune system cells that may target cell proteins specific to tumor cells.
    Location: 3 locations

  • DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

    This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It is not known if DS-3201b will work or not. This study consists of two parts. The first part (Part 1) is a dose escalation that will enroll subjects with AML or ALL that did not respond or no longer respond to previous standard therapy. The purpose of Part 1 of this research study is to determine the highest dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be enrolled at that dose into Part 2 of the study.
    Location: 4 locations

  • A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

    A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.
    Location: 4 locations

  • A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

    The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and / or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.
    Location: 4 locations

  • A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

    This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and / or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies.
    Location: 2 locations

  • A Phase Ib / II Multicenter Open-label Study of BGB324 in Patients With AML or MDS

    A Phase Ib / II multicentre open label study of BGb324 as a single agent in patients with AML or MDS or in a combination with cytarabine and decitabine in AML patients. BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor which is overexpressed in up to half of AML cases.
    Location: 2 locations

  • Abbreviated Mycophenolate Mofetil and Sargramostim after Stem Cell Transplant in Treating Patients with High Risk or Recurrent Hematological Malignancies

    This randomized phase II trial studies how well a shortened course of treatment with mycophenolate mofetil after stem cell transplant works when given with sargramostim in treating patients with a cancer that affects the blood or bone marrow (hematological malignancy), and is at high risk for returning or came back after previous treatment (recurrent). Graft versus host disease (GVHD) is a condition that may occur after transplant, in which the stem cells that are transplanted from a donor (the "graft") attack the normal cells of the patient (the “host”). Mycophenolate mofetil is used to help prevent GVHD after transplants. Giving mycophenolate mofetil for a shorter period of time may help the transplanted cells engraft with the patient's body more quickly, which may help the patient recover after the transplant. After transplants, colony-stimulating factors, such as filgrastim, are also given to help keep the bone marrow working to fight infections until it can recover from the transplant. Sargramostim may be a more effective treatment for supporting the bone marrow function than standard treatment with filgrastim. It is not yet known whether giving abbreviated treatment with mycophenolate mofetil and sargramostim is more effective than longer treatment given with filgrastim in treating patients with high risk or recurrent hematological malignancies after transplant.
    Location: Virginia Commonwealth University / Massey Cancer Center, Richmond, Virginia

  • Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients

    This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission (CR) after allogeneic stem cell transplantation. Oral crenolanib will be administered daily post-transplant for up to two years.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Reduced-Intensity Conditioning before Donor Stem Cell Transplant in Treating Patients with High-Risk Hematologic Malignancies

    This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies. Giving low-doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor’s T cells (donor lymphocyte infusion) before the transplant may help increase this effect.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

  • Low-Dose Donor Bone Marrow Transplant in Treating Patients with Hematologic Malignancies

    This phase I / II trial studies the side effects and the best way to give low-dose donor bone marrow transplant (BMT) and to see how well it works in treating patients with hematologic malignancies. Giving low-doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's bone marrow cells. When the healthy stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body’s normal cells (called graft-versus-host disease). Giving cyclophosphamide, tacrolimus, and mycophenolate mofetil (MMF) after transplant may stop this from happening.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Nintedanib and Azacitidine in Treating Participants with HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
    Location: Northwestern University, Chicago, Illinois

  • Pembrolizumab in Treating Patients with Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome after Donor Stem Cell Transplant

    This phase Ib trial studies the side effects of pembrolizumab and to see how well it works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome that has come back after receiving a donor stem cell transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • VSV-hIFNbeta-NIS with or without Ruxolitinib Phosphate in Treating Patients with Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, or T-cell Lymphoma

    This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS]) with or without ruxolitinib phosphate in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS and ruxolitinib phosphate may work better at treating multiple myeloma, acute myeloid leukemia and T-cell lymphoma.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Pembrolizumab in Treating Patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome, or B Cell Lymphomas after Donor Stem Cell Transplant

    This pilot phase I trial studies the side effects of pembrolizumab in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or B cell lymphomas after stem cell transplant. Monoclonal antibodies, such as pembrolizumab may block cancer growth in different ways by targeting certain cells.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Personalized NK Cell Therapy after Chemotherapy and Cord Blood Transplant in Treating Patients with Myelodysplastic Syndrome, Leukemia, Lymphoma or Multiple Myeloma

    This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1 / x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2 / C2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w / Subsequent Ph 2 Cohorts for AML and MDS

    Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed / refractory AML or MDS. Phase 2 will investigate overall response rate of OXi4503 in combination with intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up to 1 prior chemotherapy regimen (Arm B).
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients with Relapsed Hematologic Cancers Undergoing a Second or above Donor Stem Cell Transplant

    This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second or above donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois


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