Clinical Trials Using Fludarabine Phosphate

Clinical trials are research studies that involve people. The clinical trials on this list are studying Fludarabine Phosphate. 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 110
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  • 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

  • A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed / Refractory Indolent Non-Hodgkin Lymphoma

    This study will enroll approximately 160 adult subjects who have relapsed or refractory (r / r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
    Location: 14 locations

  • Study of Ipilimumab after Stem Cell Transplantation in Patients with Relapsed / Refractory Multiple Myeloma

    This phase I / II trial studies the best dose and effect of ipilimumab given after stem cell transplantation in treating patients with multiple myeloma that has come back (relapsed) and does not respond to treatment (refractory). Ipilimumab is an immunotherapy drug; it boosts the immune system's ability to fight cancer. 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. Giving ipilimumab after stem cell transplantation may shrink or stabilize cancer for a longer period of time than the usual approach alone.
    Location: 7 locations

  • Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed / Refractory Large B Cell or Follicular Lymphoma

    The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
    Location: 6 locations

  • Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMT CTN 1507)

    This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell disease (SCD). Based on their age and entry criteria patients are stratified into two groups: (1) children with SCD with strokes; and (2) adults with severe SCD.
    Location: 7 locations

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

    A phase 1 / 2 study to assess the safety and efficacy of MB-102 in patients with relapsed or refractory BPDCN
    Location: 5 locations

  • Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita

    Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically causing failure of the blood system. Lung disease, liver disease and cancer are other frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood system but can make the lung and liver disease and risk of cancer worse, because of DNA damaging agents such as alkylators and radiation that are typically used in the procedure. Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA damaging agents in patients with DC, and still have a successful BMT. In this protocol we will test whether a regimen that avoids DNA alkylators and radiation can permit successful BMT without compromising survival in patients with DC.
    Location: 5 locations

  • Axicabtagene Ciloleucel for the Treatment of Relapsed / Refractory Primary or Secondary Central Nervous System Lymphoma

    This phase I trial studies the side effects of axicabtagene ciloleucel (axi-cel) in treating patients with primary or secondary central nervous system lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Axi-cel is a chimeric antigen receptor (CAR) T-cell therapy that is manufactured using a patient's own white blood cells. A virus is used to introduce a gene that creates a protein (called a CAR) on the surface of T cells, a type of blood cell that fights infection and can eliminates cancer cells. With axi-cel, the CAR on the T cells may bind to and kill cells that express CD19, a molecule that may be found on B-cell lymphomas. This purpose of this trial is to test the effect and safety of axi-cel in treating patients with primary or secondary central nervous system lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel.
    Location: 2 locations

  • CIML NK Cells and Nogapendekin Alfa Alone or in Combination with Ipilimumab for the Treatment of Recurrent or Metastatic Head and Neck Cancer

    This phase I trial investigates the side effects and best dose of CIML-NK cells when given together with nogapendekin alfa alone or in combination with ipilimumab, in treating patients with head and neck squamous cell cancer that has come back (recurrent) or spread to other places in the body (metastatic). CIML NK cells come from a haploidentical donor (cells from another person with similar immune proteins). They have been bathed in special proteins to help identify and treat certain cancers. Nogapendekin alfa works by using the body’s immune system and stimulating it to increase the number of immune cells that kill tumor cells. 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. The purpose of this trial is to obtain information on the safety and effectiveness of this combination of study drugs to treat head and neck cancer.
    Location: 2 locations

  • Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) after Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors

    This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patients own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.
    Location: 2 locations

  • Genetically Engineered Cells (CD22-CAR T Cells) for the Treatment of Recurrent or Refractory B Cell Malignancies

    This phase Ib trial studies the side effects and how well cell therapy (CD22-CAR T cells) works for the treatment of B cell malignancies that have come back (recurrent) and does not respond to treatment (refractory). The antigen CD22 is commonly found on B cell cancers. In this study, a CD22 gene and a type of virus (lentivirus; a virus similar to HIV) are used in making the cells (CD22-CAR T cells). The chimeric antigen receptor (CAR) is a genetically-engineered receptor made so that immune cells can recognize and respond to a specific molecule, such as CD22 protein. This uses a portion of an antibody to CD22 and part of a molecule that activates or ‘turns on’ the immune cell. Together, the CAR may help these T cells find the cancer in the body. Giving chemotherapy (fludarabine and cyclophosphamide) before CD22-CAR T cells may help prepare the immune system to accept the CD22-CAR T cells.
    Location: 2 locations

  • Cell Therapy (CIML NK Cells) for the Treatment of Recurrent Myeloid Disease after Donor Blood Stem Cell Transplant

    This phase I trial studies the side effects and best dose of cell therapy (CIML NK cells) in treating patients with myeloid disease that has come back (recurrent) after undergoing a donor blood stem cell transplant. Drugs used in chemotherapy, such as fludarabine 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. CIML NK cells may recognize and kill cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill myeloid cells. Giving CIML NK cells with aldesleukin may increase the levels of NK cells and kill more myeloid cells.
    Location: 2 locations

  • Venetoclax, Busulfan, Fludarabine, and Azacitidine in Treating Patients with High Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelodysplastic / Myeloproliferative Neoplasm Overlap Syndromes Undergoing Donor Stem Cell Transplantation

    This phase I trial studies the best dose and side effects of venetoclax when given together with busulfan, fludarabine, and azacitidine in treating patients with high risk acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, or myelodysplastic syndrome / myeloproliferative neoplasm undergoing donor hematopoietic stem cell transplantation. Drugs used in chemotherapy, such as venetoclax, busulfan, fludarabine, and 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.
    Location: 2 locations

  • 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: 2 locations

  • AntiCD19 Chimeric Antigen Receptor T-Cells and Chemotherapy in Treating Patients with Recurrent or Refractory CD19 Positive Non-Hodgkin Lymphoma

    This phase I trial studies the side effects and best dose of autologous anti-CD19 CAR-CD3zeta-4-1BB-expressing T-cells (antiCD9 chimeric antigen receptor T-cells) when given together with chemotherapy in treating patients with CD19 positive non-Hodgkin lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Therapy with antiCD9 chimeric antigen receptor T-cells works by removing T cells from the blood and modifying them to be able to target cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, 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, and may work to suppress the immune system and allow antiCD9 chimeric antigen receptor T-cells to work better. Giving antiCD9 chimeric antigen receptor T-cells and chemotherapy may work better in treating patients with non-Hodgkin lymphoma.
    Location: 2 locations

  • Modified Immune Cells (GD2 Specific Chimeric Antigen Receptor and IL-15 Expressing Autologous Natural Killer T-Cells) in Treating Children with Relapsed or Refractory Neuroblastoma

    This phase I trial studies the best dose and side effects of GD2 specific chimeric antigen receptor (CAR) and interleukin-15 (IL-15) expressing autologous natural killer T-cells (G28z.15 NKTs) in treating children with neuroblastoma that has come back or does not respond to treatment. This trial combines two different ways of fighting cancer: antibodies and natural killer T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. GD2-CAR natural killer T cells are modified immune cells that have been engineered in the laboratory to specifically target GD2 proteins found on neuroblastoma tumor cells and kill them. IL-15 is critical for the development and maintenance of T cells. These new cells may be able to slow the growth of tumor cells in patients with neuroblastoma.
    Location: 2 locations

  • CD19 / CD22 Chimeric Antigen Receptor T Cells and Chemotherapy in Treating Children or Young Adults with Recurrent or Refractory CD19 Positive B Acute Lymphoblastic Leukemia

    This phase I trial studies the best dose and side effects of CD19 / CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19 / CD22 proteins. These proteins are commonly found on B acute lymphoblastic leukemia. 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. Giving CD19 / CD22-CAR T cells and chemotherapy may work better in treating children or young adults with B acute lymphoblastic leukemia.
    Location: 2 locations

  • Modified Immune Cells (GPC3-CAR T cells) for the Treatment of Relapsed or Refractory Pediatric Solid Tumors

    This phase I trial studies the side effects and best dose of GPC3-CAR T cells in treating pediatric patients with solid tumors that have come back or do not respond to treatment. This study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. In the laboratory, new genes called chimeric antigen receptors (CARs) are made from an antibody called GC33 that recognizes glypican-3, a protein found on solid tumors (GPC3-CAR). T cells genetically engineered with a GPC3-CAR may recognize cancer cells and kill them.
    Location: 2 locations

  • Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

    This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).
    Location: 2 locations

  • Testing CAR-T Cell Therapy in Recurrent Epithelial Ovarian Cancer

    This phase I trial is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3 T cells) in patients with ovarian cancer that has come back (recurrent). CAR.B7-H3 T cells combine two different ways the body fights cancer, antibodies and T cells. Antibodies are proteins that protect the body from foreign invaders like bacteria. Antibodies work by attaching to these bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection fighting blood cells that can kill viruses and other cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancer. They both have shown promise, but neither alone has been able to cure most patients. This study will combine both T cells and antibodies to create a more effective treatment.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Chemotherapy and Cord Blood Transplant in Children and Young Adults with Hematologic Malignancies or Non-malignant Diseases

    This phase II trial studies the effect of chemotherapy and a cord blood transplant in children and young adults with hematologic malignancies or non-malignant diseases. Chemotherapy drugs, such as clofarabine, fludarabine, and busulfan, 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. Before receiving stem cells, the standard process, called cytoreduction, is to receive high doses of chemotherapy. This helps to make room in the bone marrow for new blood stem cells to grow, helps prevent the body from rejecting the transplanted cells, and helps kill any cancer cells that are in the body. This is called a conditioning regimen. However, high doses of chemotherapy can have serious side effects. This study may help researchers learn whether combining the chemotherapy drugs clofarabine, fludarabine, and busulfan is a safe and effective way to reduce the side effects from receiving a conditioning regimen in children and young adults receiving cord blood transplants.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Anti-CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

    This phase I trial investigates the best dose and side effects of autologous anti-CD19 chimeric antigen receptor (CAR)-expressing T lymphocytes (anti-CD19 CAR T cells) in treating patients with B-cell non-Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Treatment with anti-CD19 CAR T cells uses a patient's own immune cells, called T cells (a type of white blood cell), to kill lymphoma. T cells fight infections and, in some cases, may also kill cancer cells. In this trial, some of the patient's T cells will be removed from the blood, modified in a laboratory, and infused back into the patient by intravenous (IV) administration. In the laboratory, a new gene is inserted into the T cells that may target and kill lymphoma cells. This process of putting a new gene into the T cells uses a weakened virus, modified so that it cannot multiply or spread. The modified T cells are called “genetically modified T cells.” In this trial, they are called “anti-CD19 CAR T cells.”
    Location: University of California San Francisco, San Francisco, California

  • Donor Stem Cell Transplant after Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults

    This phase II trial investigates side effects and how well donor stem cell transplant after chemotherapy works in treating pediatric and adolescent-young adults with high-risk solid tumor that has come back (recurrent) or does not respond to treatment (refractory). Chemotherapy drugs, such as fludarabine, thiotepa, etoposide, melphalan, and rabbit anti-thymocyte globulin 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 chemotherapy before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.
    Location: M D Anderson Cancer Center, Houston, Texas

  • CISH Inactivated Tumor-Infiltrating Lymphocytes for the Treatment of Metastatic Gastrointestinal Epithelial Cancer

    This phase I / II trial evaluates the side effects and best dose of CISH inactivated tumor-infiltrating lymphocytes in patients with gastrointestinal epithelial cancer that has spread to other places in the body (metastatic). CISH inactivated tumor-infiltrating lymphocytes are created from immune cells extracted from a patient's own tumor cells. The immune cells are modified to make them more effective at finding and killing tumor cells. The purpose of this trial is to determine if CISH inactivated tumor-infiltrating lymphocytes are safe and effective as a treatment for gastrointestinal epithelial cancer.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Fludarabine and CPX-351 for the Treatment of Newly-Diagnosed Acute Myeloid Leukemia

    This phase II trial investigates how well fludarabine and CPX-351 work in treating patients with newly-diagnosed acute myeloid leukemia. Chemotherapy drugs, such as fludarabine and CPX-351, 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: University of California San Diego, San Diego, California


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