Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Heparin-Induced ThrombocytopeniaThe purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation...
Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAdult Acute Lymphoblastic Leukemia in Remission8 moreThis phase I trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, and donor bone marrow transplant, and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has spread to nearby or other places in the body (advanced), or high-risk myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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. Giving cyclophosphamide together with mycophenolate mofetil and tacrolimus after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, fludarabine phosphate, cyclophosphamide, mycophenolate mofetil, and tacrolimus may be an effective treatment for advanced acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes.
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
Autoimmune CytopeniasThe majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP), autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will respond to conventional immunosuppressive therapy with or without splenectomy. There is, however, a group of patients with refractory or chronically relapsing autoimmune cytopenias causing life-threatening hemorrhages, infections or anemia. Further problems include the short- and long-term side-effects of corticosteroids, and the potential toxicity of immunosuppressive and cytotoxic agents. An alternative and less toxic approach in these patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific for the CD52 antigen and present on human lymphocytes and monocytes. The main effect of Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and CD8 subpopulations, particularly the CD4 population, and this might "reset" the immune system without the need for total immune ablation.Therefore, this study is designed to investigate safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to minimize possible side effects of accumulating Campath, the 3 treatment cycles will be administered in consecutively reduced doses.
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment...
Brain and Central Nervous System TumorsDrug/Agent Toxicity by Tissue/Organ2 moreRATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid...
Heparin-induced ThrombocytopeniaAn Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)
Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis
AnemiaASXL1 Gene Mutation8 moreThis phase II trial studies how well busulfan, fludarabine, donor stem cell transplant, and cyclophosphamide in treating participants with multiple myeloma or myelofibrosis. Drugs used in chemotherapy, such as busulfan, 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. Giving chemotherapy 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 participant they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving busulfan and fludarabine before and cyclophosphamide after donor stem cell may work better in treating participants with multiple myeloma or myelofibrosis.
Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective...
ThrombosisVenous4 moreVenous thromboembolism (VTE) is the second leading cause of death in patients with cancer, after disease progression. VTE is increasingly recognized as a complication in patients with hematologic malignancies and various studies have reported high rates of VTE. Critically ill patients are at high risk of VTE and should all receive thromboprophylaxis. Given the increasing number of patients with HM (hematologic malignancies) / HCT (Hematopoietic cell transplantation) who develop critical illness, and their often prolonged course, it is imperative to understand the incidence and risk factors for VTE, and to evaluate the efficacy and risks associated with both chemical and mechanical thromboprophylaxis Therefore, the investigators plan to evaluate retrospectively the VTE / PE (pulmonary embolism) incidence in HM /HCT patients at the University of Toronto, and the complications associated with it (including death). In addition, the investigators want to evaluate the use, type (mechanical or pharmacological) and timing of thromboprophylaxis. And lastly, the investigators will determine the incidence of bleeding and of complications associated with chemical and mechanical thromboprophylaxis. The investigators will describe the change in VTE incidence over the last 10 years. The investigators know that patients with COVID-19 infection are at higher risk of thrombosis than non-COVID patients. As such, HM/HCT COVID-19 pts will comprise a subgroup, which will be compared with patients who are not not positive for COVID-19. If these numbers are low, COVID-19 status will be included as a predictive variable in our modelling. The results of this research program will help define indications and safety of VTE prophylaxis; and will inform the development of clinical practice guidelines.
A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International...
ThrombocytopaeniaEltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.
Function of Platelets Used for Transfusions
ThrombocytopeniaHematologic MalignancyCytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream. We have developed a method with flow cytometry to measure platelet function markers. It allows us to determine which pathways that are initiated upon activation. The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient. The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.
Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia...
Heparin-induced ThrombocytopeniaHeparin is an anticoagulant (blood thinner) that is commonly used to treat patients with heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some patients develop an allergic reaction to heparin, a condition called heparin-induced thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and death. The objective of this 200 patient study is to determine if a new blood thinner called rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not require blood testing, and had a low risk of bleeding when it was used to treat blood clots in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT, there will be two very important benefits. For patients with HIT, the benefit will be having a safe, and easy-to-use drug to protect them from developing further life or limb-threatening blood clots. For the Canadian health care system, the benefit will be having a drug that is much less expensive than the drugs currently used to treat HIT.