Treatment Clinical Trials for Chronic Myelogenous Leukemia (CML)

Clinical trials are research studies that involve people. The clinical trials on this list are for chronic myelogenous leukemia (cml) 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.

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  • Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients with Chronic Myeloid Leukemia

    This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 449 locations

  • Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

    This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. 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. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic myeloid leukemia.
    Location: 199 locations

  • Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

    The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must meet the definition of treatment failure as per the 2013 ELN guidelines. Patients with documented treatment failure while on bosutinib treatment will have the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.
    Location: 13 locations

  • Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard Umbilical Cord Blood in Patients With Leukemia, Lymphoma, and Myelodysplastic Syndrome (MDS)

    This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.
    Location: 14 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 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.
    Location: 6 locations

  • A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL

    The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
    Location: 6 locations

  • Safety, Tolerability, Pharmacokinetics and Activity of K0706

    Phase 1 / 2 study to determine safety, tolerability, pharmacokinetics and activity of K0706
    Location: 5 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

  • Donor Stem Cell Transplant in Treating Patients With Hematological Malignancies Who Have Undergone Donor Stem Cell Transplant

    In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, researchers would like to specially treat the donor's blood cells to remove cells that are most likely to attack patients' tissues. This will occur in combination with intense conditioning treatment that patients will receive before having a transplant.
    Location: 3 locations

  • ABL001, Dasatinib, and Prednisone in Treating Patients with BCR-ABL Positive B-Cell Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia

    This phase I trial studies the side effects and best dose of ABL001 when given together with dasatinib and prednisone in treating patients with BCR-ABL positive B-cell acute lymphoblastic leukemia or chronic myeloid leukemia. ABL001 and dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Prednisone may help to lessen inflammation and lower the body's immune response. Giving ABL001, dasatinib, and prednisone may work better in treating patients with BCR-ABL positive B-cell acute lymphoblastic leukemia or chronic myeloid leukemia.
    Location: 3 locations

  • PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

    The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
    Location: 4 locations

  • A Phase II Trial of CD24Fc for the Prevention of Acute GVHD Following Myeloablative Allogeneic HSCT

    This is a multicenter prospective randomized phase IIa / II Expansion clinical trial designed to determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host Disease) prophylaxis. Funding Source - FDA OOPD
    Location: 4 locations

  • Selective Depletion of CD45RA+ T Cells from Allogeneic Peripheral Blood Stem Cell Grafts from HLA-Matched Related and Unrelated Donors in Preventing GVHD

    This phase II trial is for patients with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who have been referred for a peripheral blood stem cell transplantation to treat their cancer. In these transplants, chemotherapy and total-body radiotherapy ('conditioning') are used to kill residual leukemia cells and the patient's normal blood cells, especially immune cells that could reject the donor cells. Following the chemo / radiotherapy, blood stem cells from the donor are infused. These stem cells will grow and eventually replace the patient's original blood system, including red cells that carry oxygen to our tissues, platelets that stop bleeding from damaged vessels, and multiple types of immune-system white blood cells that fight infections. Mature donor immune cells, especially a type of immune cell called T lymphocytes (or T cells) are transferred along with these blood-forming stem cells. T cells are a major part of the curative power of transplantation because they can attack leukemia cells that have survived the chemo / radiation therapy and also help to fight infections after transplantation. However, donor T cells can also attack a patient's healthy tissues in an often-dangerous condition known as Graft-Versus-Host-Disease (GVHD). Drugs that suppress immune cells are used to decrease the severity of GVHD; however, they are incompletely effective and prolonged immunosuppression used to prevent and treat GVHD significantly increases the risk of serious infections. Removing all donor T cells from the transplant graft can prevent GVHD, but doing so also profoundly delays infection-fighting immune reconstitution and eliminates the possibility that donor immune cells will kill residual leukemia cells. Work in animal models found that depleting a type of T cell, called naive T cells or T cells that have never responded to an infection, can diminish GVHD while at least in part preserving some of the benefits of donor T cells including resistance to infection and the ability to kill leukemia cells. This clinical trial studies how well the selective removal of naive T cells works in preventing GVHD after peripheral blood stem cell transplants. This study will include patients conditioned with high or medium intensity chemo / radiotherapy who can receive donor grafts from related or unrelated donors.
    Location: 2 locations

  • Donor T Cell Depletion in Preventing Graft Versus Host Disease in Patients with Blood Cancer Undergoing a Donor Stem Cell Transplant

    This phase II trial studies donor T cell depletion in preventing graft versus host disease (GVHD) in patients with blood cancer undergoing a donor stem cell transplant. Donor stem cell transplants, especially in the mismatched donor setting, are associated with increased risk for GVHD, a condition where the transplanted donor white blood cells attack your body’s normal tissues. Using a cell separation device may remove a subset of white blood cells (called alpha / beta T cells) from the donor product before the product is transplanted. This study is being done to assess whether this manipulation (called selective T cell depletion) will reduce the risk of GVHD and improve transplant outcome.
    Location: Dana-Farber Cancer Institute, Boston, Massachusetts

  • Laboratory Expanded Umbilical Cord Blood Product (Spanlecortemlocel) in Treating Patients with High-Risk Blood Cancers

    This phase II trial studies how the transplantation of laboratory expanded cord blood, called spanlecortemlocel, works in treating patients with high-risk blood cancers. Umbilical cord blood transplantation has been primarily used in patients with blood cancers. However, the blood counts are slower to recover after this type of transplantation, which can result in a longer hospital stays and a greater number of transfusions. To speed up blood count recovery, the number of blood forming stem cells can be multiplied more than 300 times on average in the laboratory prior to transfusion. Using spanlecortemlocel may speed up blood count recovery in patients with high-risk blood cancers.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Edetate Calcium Disodium or Succimer in Treating Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy

    This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and / or improve response to chemotherapy.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Donor Stem Cell Transplant using Alpha / Beta+ T-Cell Depletion in Treating Patients with Hematologic Malignancies

    This phase II trial studies the side effects of donor stem cell transplant using allogeneic TCR alpha / beta-positive T-lymphocyte-depleted peripheral blood stem cells (alpha / beta positive [+] T-cell depletion) in treating patients with hematologic malignancies. 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft-versus-host disease. Removing the T cells from the donor cells before the transplant may stop this from happening.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

    To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Venetoclax, Ponatinib, and Dexamethasone in Participants with Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

    This phase I / II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia or chronic myelogenous leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as venetoclax and dexamethasone, 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. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, ponatinib, and dexamethasone may work better in treating participants with acute lymphoblastic leukemia or chronic myelogenous leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Reduced Intensity Chemotherapy and Total Body Irradiation before TCR-alpha / beta+ T-lymphocytes Donor Transplant in Treating Participants with High-Risk Myeloid Diseases

    This phase I trial studies how well reduced intensity chemotherapy and total-body irradiation before allogeneic TCR alpha / beta-positive T-lymphocyte-depleted peripheral blood stem cells (TCR-alpha / beta+ T-lymphocytes donor transplant) works in treating participants with high-risk myeloid diseases. Giving chemotherapy such as anti-thymocyte globulin and fludarabine phosphate, as well as total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the participant's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the participant they may help the participant'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). Removing the T cells from the donor cells before the transplant may stop this from happening.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Recombinant EphB4-HSA Fusion Protein and Cytarabine / or Vincristine Liposomal in Treating Participants with Recurrent or Refractory Acute Leukemia

    This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with cytarabine or vincristine liposomal in treating participants with acute leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as recombinant ephb4-HSA fusion protein, cytarabine, and vincristine liposomal, 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 the drugs in different combinations may kill more cancer cells.
    Location: USC / Norris Comprehensive Cancer Center, Los Angeles, California

  • Cyclophosphamide, Fludarabine Phosphate, and Total Body Radiation, before Donor Stem Cell Transplant in Treating Participants with Blood Disorders and Blood Cancers

    This phase III trial studies how well cyclophosphamide, fludarabine phosphate, and total body radiation before donor stem cell transplant work in treating participants with blood disorders and blood cancers. Giving chemotherapy such as cyclophosphamide and fludarabine phosphate and total body radiation before a stem cell transplant helps stop the growth of cells in the bone marrow. When the healthy cells from a donor are infused into the participant, they may help the patient's bone marrow make stem cells, red blood cells, and platelets. The donated cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
    Location: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

  • Tocilizumab in Improving Graft-Versus-Host Disease and Early Side Effects in Patients with Blood Cancers Undergoing Umbilical Cord Blood Transplant

    This phase II trial studies how well tocilizumab works in improving graft-versus-host disease (GVHD) and early side effects in patients with blood cancers undergoing umbilical cord blood transplant. Giving chemotherapy and total-body irradiation before an umbilical cord blood 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called GVHD). Giving tocilizumab in addition to the standard approach for GVHD prevention after the transplant may stop this from happening.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Thiotepa, Fludarabine Phosphate, and Melphalan Hydrochloride in Treating Patients with Blood Cancer Undergoing Donor Stem Cell Transplant

    This phase II trial studies how well thiotepa, fludarabine phosphate, and melphalan hydrochloride work in treating patients with blood cancer who are undergoing a donor stem cell transplant. Drugs used in chemotherapy, such as thiotepa, fludarabine phosphate, and melphalan hydrochloride 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: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients with Blood Cancer

    This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps 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. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells.
    Location: Roswell Park Cancer Institute, Buffalo, New York


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