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 136
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  • 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: 15 locations

  • Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

    This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia that has come back or has not responded to treatment or high-risk myelodysplastic syndrome that has come back. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, and fludarabine phosphate, and cytarabine, 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 more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.
    Location: 16 locations

  • Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

    This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6). The primary objectives of this study are: - Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens - Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel - Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities
    Location: 15 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

  • 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: 8 locations

  • Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

    This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival.
    Location: 7 locations

  • Eliminating Total Body Irradiation before a Donor Stem Cell Transplant in Treating Younger Patients with NGS-MRD Negative B-Acute Lymphoblastic Leukemia, the EndRAD Trial

    This phase II trial studies how well eliminating total body irradiation (TBI) before a donor stem cell transplant works in treating younger patients with next-generation sequencing (NGS) minimal residual disease (MRD) negative B-acute lymphoblastic leukemia. TBI is normally used with chemotherapy in a conditioning regimen before a donor stem cell transplant and is considered related to improved outcomes. However, TBI has negative impacts on long-term growth and cognitive function of children and young adults. This study evaluates whether or not patients with NGS-MRD negative B-acute lymphoblastic leukemia have the same or similar medical outcome if they do not receive TBI before a donor stem cell transplant.
    Location: 5 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: 5 locations

  • Vaccine Therapy after Donor Stem Cell Transplant in Treating Patients with Advanced Myelodysplastic Syndrome or Acute Myeloid Leukemia

    This randomized phase II trial studies how well vaccine therapy after donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has spread to other places in the body (advanced). Vaccines made from a gene-modified virus and a person's tumor cells may help the body build an immune response to kill cancer cells. Giving chemotherapy before a donor peripheral blood or bone marrow transplant helps stop the growth of 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. It is not yet known whether giving vaccine therapy after a donor peripheral blood or bone marrow transplant is more effective than transplant alone in treating myelodysplastic syndrome or acute myeloid leukemia.
    Location: 4 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: 4 locations

  • Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed / Refractory HPV16+ Cancers

    This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in human leukocyte antigen (HLA)-A*02:01+ adults with relapsed / refractory human papillomavirus (HPV)16+ cancers.
    Location: 4 locations

  • Donor Bone Marrow Transplant Followed by Chemotherapy in Treating Patients with Relapsed or Refractory Severe Aplastic Anemia or Other Bone Marrow Failure Syndromes

    This phase II trial studies donor bone marrow transplant followed by chemotherapy in treating patients with severe aplastic anemia that has come back (relapsed) or does not respond to treatment (refractory), or other bone marrow failure syndromes. Infusing stem cells from a donor into a patient may help the patient’s bone marrow make stem cells, red 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). Currently, treatment to suppress the immune system is given before transplant to stop graft-versus-host disease from happening. Giving treatment to suppress the immune system after the transplant may work better in stopping graft-versus-host disease, and may help increase the number of donors for a patient by allowing people with stem cells that do not exactly match the patient to be donors. Giving treatment to suppress the immune system after the transplant may work better in stopping graft-versus-host disease, and may increase the amount of possible donors for a patient by better preventing graft-versus-host disease.
    Location: 3 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: 3 locations

  • Treosulfan and Fludarabine Phosphate before Donor Stem Cell Transplant in Treating Patients with Nonmalignant Inherited Disorders

    This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or without low dose radiation before donor stem cell transplantation works in treating patients with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown to be curative for many patients with nonmalignant (noncancerous) diseases such as primary immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and / or radiation are often used to condition the patient before infusion of the new healthy donor cells. The purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which doesn't work properly in order to make way for the new healthy donor cells which functions normally. Although effective in curing the patient's disease, many hematopoietic cell transplantation regimens use intensive chemotherapy and / or radiation which can be quite toxic, have significant side effects, and can potentially be life-threatening. Investigators are investigating whether a new conditioning regimen that uses less intensive drugs (treosulfan and fludarabine phosphate) with or without low dose radiation results in new blood-forming cells (engraftment) of the new donor cells without increased toxicities in patients with nonmalignant (noncancerous) diseases.
    Location: 3 locations

  • Venetoclax, Busulfan and Fludarabine in Treating Patients with 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 and fludarabine in treating patients with 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 and fludarabine, 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

  • 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

  • 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

  • Giving Chemotherapy and rATG for a Shortened Amount of Time before a Donor Stem Cell Transplantation for the Treatment of Patients with Blood Cancers

    This phase I trial studies the side effects of giving chemotherapy and a drug called rATG for a shortened amount of time before a donor stem cell transplant in treating patients with blood cancers. A chemotherapy regimen with the drugs busulfan, melphalan, and fludarabine kill cancer cells in the body, making room in the bone marrow for new blood stem cells to grow and reducing the chance of transplanted cell rejection. The chemotherapy drugs work to interrupt the DNA (genetic information) in the cancer cells, stopping the cells from dividing and causing them to die. rATG targets and deactivates white blood cells called T cells that survive the chemotherapy. T cells may see the donor’s cells as foreign, causing a serious condition called graft-versus-host disease (GVHD). rATG helps prevent the donor stem cells from being rejected. Giving chemotherapy and rATG for a shortened amount of time before a donor stem cell transplant may help reduce the number of side effects and shorten hospitalization following the transplantation.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Recurrent or Refractory B Cell Malignancies or Acute Lymphoblastic Leukemia

    This phase I / Ib trial studies the side effects and best dose of autologous CD22 CAR T cells and to see how well it works in treating patients with B cell malignancies or acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. In this study, some of patients' immune cells (called T cells) will be collected during a procedure called ‘leukapheresis’, and genetically modify them to recognize the antigen (marker) CD22 on cancer cells. CD22 is commonly found on B cell cancers. The CAR is a genetically-engineered receptor made recognize a specific molecule, which in this study is the CD22 protein, and activate or ‘turn on’ immune cells. Doctors use a type of virus to introduce the CAR receptor into patients' T cells to make the CD22 CAR T cells, so they may find and kill those cancer cells in the body.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Genetically Engineered Cells (ATLCAR.CD30 T Cells) for the Treatment of Relapsed or Refractory CD30 Positive Peripheral T Cell Lymphoma

    This phase II trial studies how well genetically engineered cells (ATLCAR.CD30 T cells) work in treating patients with CD30 positive peripheral T cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T cells are special types of blood cells. They can find and destroy other cells that may cause disease or cancer. However, sometimes cancer cells can hide from T cells and grow into tumors. Genes make up the chemical structure carrying information that may determine human characteristics (i.e., eye color, height and sex). In this study, a gene that makes an antibody called anti-CD30 is put inside T cells, which may make T cells better at recognizing and destroying CD30 positive peripheral T cell lymphoma cancer cells.
    Location: 2 locations

  • Lymphodepletion with Adoptive Cell Therapy and High-Dose IL-2 for the Treatment of Metastatic Soft Tissue Sarcoma in Young Adult Patients

    This phase I trial studies the side effects of adoptively transferred tumor-specific T cells and high-dose aldesleukin (IL-2) and to see how well they work in treating patients with soft tissue sarcoma that has spread to other parts of the body (metastatic). Fludarabine and cyclophosphamide are two types of chemotherapy drugs used in lymphodepletion. The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the body before tumor infiltrating lymphocytes are infused. This is so that there will be more “space” for the lymphocytes that will be infused in the veins.Tumor-infiltrating lymphocytes involve the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system. These special immune T-cells are taken from a sample of tumor tissue that is surgically removed, then multiplied in a laboratory, and infused back into the patient. IL-2 may help the body's response to treatment on the immune system.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Phase I Study of Autologous huMNC2-CAR44 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)

    Phase I study of adoptive immunotherapy for advanced MUC1* positive breast cancer with autologous T cells engineered to express a chimeric antigen receptor, huMNC2-CAR44 specific for a cleaved form of MUC1 (MUC1*)
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Optimizing PTCy Dose and Timing

    Background: Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor cells see the recipient s body as foreign. This can cause complications. A high dose of the drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower dose of PTCy can have the same benefits. Objective: To see if a lower dose of PTCy will help people with blood cancers have a more successful transplant and fewer side effects. Eligibility: People ages 15-65 with leukemia, lymphoma, or multiple myeloma that is not curable with standard therapy and is at high risk of returning without transplant, and their healthy adult relatives Design: Transplant participants will be screened with: Blood, urine, breathing, and heart tests Scans Chest x-ray Bone marrow samples: A needle inserted into the participant s pelvis will remove marrow and a bone fragment. Transplant recipients will stay at the hospital and be prepped with chemotherapy over 6 days for the transplant. They will get stem cells through a catheter in the chest or neck. They will get the cyclophosphamide chemotherapy. They will stay in the hospital about 4 more weeks. They will have blood transfusions. They will have frequent blood tests and 2 bone marrow samples within 1 year after the transplant. Donor participants will be screened with: Blood, urine, and heart tests Chest x-ray Scans Donor participants will have bone marrow taken from their pelvis or stem cells taken from their blood. For the blood donation, blood will be taken from a vein in one arm, move through a machine to remove white blood cells, and be returned through a vein in the other arm. Participation will last up to 5 years....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland


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