TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group...
Chronic Myeloid LeukemiaAdvances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to recurrence of disease in the majority of patients. The trial aims to improve treatment strategies in CML by improving induction therapy and deescalating maintenance therapy using low dose IFN as inducer of immunosurveillance. The trial will provide important data on the duration of active therapy in CML patients. Considering the rapidly increasing prevalence of CML this is of individual but also socioeconomic importance.
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD...
Acute Myeloid LeukemiaTo determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
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.
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.
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.
Effect of Imatinib on Bone Metabolism in Patients With Chronic Myelogenous Leukemia or Gastrointestinal...
Gastric CancerLeukemia1 moreThe drug that you are taking for your cancer, imatinib (GleevecTM), has recently been shown to have some new types of side effects. In some people, imatinib can affect how bones are made. The purpose of this study is to find out if imatinib is causing these side effects in you. We can check how your bones form by testing your blood and urine. We can also check your bone strength by doing a special X-ray of your bone called bone density (or DEXA scan).