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.
UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia / Myelodysplasia
Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients with blood cancers. Cord blood (CB) represents an alternative source of stem cells, which is associated with a lower risk of relapse, especially in the presence of minimal residual disease in the setting of acute leukemia and myelodysplasia. Furthermore, CB has the added advantage of being associated with a low risk of chronic graft versus host disease (GVHD). Unfortunately, CB transplants are hampered by a higher risk of transplant related mortality (TRM) when compared to bone marrow / peripheral blood transplants because of the limited cell dose of CB. In the previous UM171 trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as >80% of patients received a 6-7 / 8 HLA matched CB. Interestingly there were 5 patients who had already failed an allogeneic transplant and 5 patients with refractory / relapsed acute leukemia / aggressive lymphoma. Despite this high risk population, progression was 20% at 12 months. Hence, in this new trial, investigators are targeting patients with high and very high-risk acute leukemia / myelodysplasia to test the antileukemia effect of this new graft, a UM171 expanded CB.
Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington
Modified Immune Cells (CD19 / CD20 CAR-T Cells) in Treating Patients with Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia
This phase I trial studies the side effects and best dose of CD19 / CD20 chimeric antigen receptor (CAR) T-cells when given together with chemotherapy, and to see how effective they are in treating patients with non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia that has come back (recurrent) or has not responded to treatment (refractory). In CAR-T cell therapy, a patient's white blood cells (T cells) are changed in the laboratory to produce an engineered receptor that allows the T cell to recognize and respond to CD19 and CD20 proteins. CD19 and CD20 are commonly found on non-Hodgkin’s B-cell lymphoma and chronic lymphocytic leukemia cells. Chemotherapy drugs such as fludarabine phosphate and cyclophosphamide can control cancer cells by killing them, by preventing their growth, or by stopping them from spreading. Combining CD19 / CD20 CAR-T cells and chemotherapy may help treat patients with recurrent or refractory B-cell lymphoma or chronic lymphocytic leukemia.
Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California
Donor Stem Cell Transplant with Treosulfan, Fludarabine, and Thiotepa in Treating Patients with Non-malignant Disorders
This phase II trial studies how well donor stem cell transplant, treosulfan, fludarabine, and thiotepa work in treating patients with non-cancerous disorders. Giving chemotherapy before a donor 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: 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: Stanford Cancer Institute Palo Alto, Palo Alto, California
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients with Acute Leukemia
This phase II trial compares four strategies for the reduction of graft versus host disease in patients with acute leukemia in remission. 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: 2 locations
Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis after Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation
This phase II trial studies how well 3 different drug combinations prevent graft versus host disease (GVHD) after donor stem cell transplant. Calcineurin inhibitors, such as cyclosporine and tacrolimus, may stop the activity of donor cells that can cause GVHD. Chemotherapy drugs, such as cyclophosphamide and methotrexate, may also stop the donor cells that can lead to GVHD while not affecting the cancer-fighting donor cells. Immunosuppressive therapy, such as anti-thymocyte globulin (ATG), is used to decrease the body's immune response and reduces the risk of GVHD. It is not yet known which combination of drugs: 1) ATG, methotrexate, and calcineurin inhibitor 2) cyclophosphamide and calcineurin inhibitor, or 3) methotrexate and calcineurin inhibitor may work best to prevent graft versus host disease and result in best overall outcome after donor stem cell transplant.
Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington
Crohn's Allogeneic Transplant Study
This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in treating patients with refractory Crohn's Disease. We will select patients with severe Crohn's Disease and active inflammation despite the best medical and surgical treatments. These patients must be healthy enough to undergo a transplantation procedure. They cannot have an active infection, and their heart, lungs, kidneys, and liver cannot be failing. The transplant procedure starts with chemotherapy and a small dose of radiation, to weaken a patient's immune system so that it will accept bone marrow cells from another person. After that other person's bone marrow cells are given to the patient, immune suppressive medicines are given to prevent the new cells from being rejected and to stop those cells from damaging the patient. After the new donor cells start to work, blood counts will rise and the new immune system will start to grow. During this time, there is a risk of infection. Antibiotics and anti-viral drugs will be given to prevent infection. When the new donor cells are well-established, immune suppressive medicines are discontinued. We will examine parts of the intestine that were inflamed before the start of the transplant procedure, to be sure the Crohn's Disease has disappeared after the transplant. Patients will be formally evaluated for Crohn's activity at around 100 days after transplant, and yearly after that for 5 years.
Location: See Clinical Trials.gov
Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant
This phase I / II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients with Hematologic Malignancies Undergoing Donor Stem Cell Transplant
This phase Ib / II trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as 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. Giving chemotherapy and total-body irradiation before a donor stem cell 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 graft versus host disease). Giving cyclophosphamide after the transplant may stop this from happening.
Location: Roswell Park Cancer Institute, Buffalo, New York
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients with Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Location: City of Hope Comprehensive Cancer Center, Duarte, California
Ex-Vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-versus-Host Disease
This phase I trial studies donor regulatory T lymphocytes in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Regulatory T lymphocytes are a type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. Regulatory T lymphocytes may be a better treatment for preventing acute graft-versus-host disease caused by a donor stem cell transplant.
Location: Moffitt Cancer Center, Tampa, Florida