Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic...
Myelodysplastic SyndromesLeukemia6 moreContrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation...
Acute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML)3 moreBackground: - Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. Donors: age 18 80. Design: Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. Donors will be screened with medical history, physical exam, blood tests and tissue typing. Recipients will stay in the hospital 3 6 weeks. All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. Recipients will have: Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. Bone marrow sample taken by needle. They will have 3 more after transplant. Donors will have: Filgrastim injected once daily for 5 6 days. Stem and immune cells collected by another apheresis. Recipients will get: Eight 30-minute doses of radiation, sitting at a machine. Donor immune cells by IV, 6 days before the transplant day. Chemotherapy drugs by IV. <TAB><TAB>- Donor stem cells by IV on transplant day. After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections Recipients must stay near NIH for 3 6 months after transplant. All recipients and donors will have 3 years of follow-up.
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood...
Aggressive Non-Hodgkin LymphomaBlasts Under 5 Percent of Bone Marrow Nucleated Cells20 moreThis phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent 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). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
Relapsed or Refractory Acute Myeloid LeukemiaRelapsed or Refractory B-Cell Acute Lymphoblastic LeukemiaThe main purpose of this study is to test the safety and efficacy of VS-4718 in two types of leukemia patients and to find the right dose of VS-4718 for future clinical trials. Other purposes of this study include: Testing for study drug VS-4718 levels in blood over time and what happens to the study drug in patients. To find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.
Aezea® (Cenersen) and Chemotherapy for AML Subjects ≥ 55 Years of Age With No Response to Frontline...
Acute Myelogenous LeukemiaThe purpose of this study is to assess whether treatment with cenersen in combination with 4 cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show a response (CR, CRi, or PR) to a single aggressive frontline induction course.
AMD3100 With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplant for AML...
Acute Myelogenous LeukemiaMyelodysplastic SyndromesAMD3100 given in combination with busulfan, fludarabine (and thymoglobulin (ATG) for unrelated or HLA nonidentical donors) preparative regimen in patients with acute myelogenous leukemia (AML) / myelodysplastic syndromes (MDS). This study aims to determine if in AML and MDS patients there is a reduction of malignant cells and enhanced elimination of the leukemia as assessed by progression free survival. Secondary goals will be to assess effects on engraftment, graft versus host disease (GVHD) and immune reconstitution.
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute...
Acute Myeloid LeukemiaMyelodysplastic SyndromeThe goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.
Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal...
Acute Myelogenous LeukemiaMyelodysplastic SyndromeThe goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation...
Relapsed AMLT(8;21)1 moreIn this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
Acute Myeloid LeukaemiaThis is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).