An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase...
Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.
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.
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.
Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell...
B-cell Adult Acute Lymphoblastic LeukemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue21 moreThis phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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.
T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies...
Hematologic MalignancyAcute Myeloid Leukemia17 moreThis is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB) Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible without conferring grade II-IV acute graft-versus-host disease (GVHD). In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged pharmacologic immunosuppression.
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia...
Pediatric Patients With Acute Lymphoblastic LeukemiaThis is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lymphoblastic...
Acute Lymphoblastic Leukemia in Complete RemissionLymphoblastic Lymphoma in Complete Remission1 moreIn this phase I study, escalating doses of IXAZOMIB will be combined with the POMP/D regimen.
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted...
Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia1 moreThe purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.
Evaluation of ETC-1907206 With Dasatinib in Advanced Haematologic Malignancies
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Ph- Acute Lymphoblastic Leukemia (Ph-ALL)4 moreThis study evaluates the use of ETC-1907206 in combination with dasatinib in certain types of blood cancers. The first phase of the study (1A) is designed to find the highest tolerated dose of ETC-1907206, while the second phase (1B) will assess the safety and tolerability of the recommended dose of ETC-1907206. ETC-1907206 has been designed to block the activity of an enzyme of the body known as Mnk kinase, which is thought to be involved in the development of a variety of cancers.