Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating...
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAcute Myeloid Leukemia/Transient Myeloproliferative Disorder18 moreRATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of 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. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia. PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Phase II 5-Azacytidine Plus VPA Plus ATRA
Myelodysplastic SyndromeAcute Myelogenous Leukemia5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Acute Myeloblastic LeukemiaLymphoblastic Leukemia4 moreThe purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.
Oral Clofarabine for Acute Myeloid Leukemia
LeukemiaMyeloid1 moreThis is a phase I study designed to test the safety of oral clofarabine when given as consolidation therapy to older patients with AML in remission.
Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological...
LeukemiaAcute Lymphocytic (ALL)13 moreBlood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection. For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in this high risk patient population by 1) limiting the complication of graft versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3) reducing non-relapse mortality.
Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndromes and Acute Myeloid Leukemia...
Myelodysplastic Syndromes and LeukemiaMyeloid1 moreThis study is designed to test the combination of decitabine, arsenic trioxide and ascorbic acid in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia
GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade...
Acute Undifferentiated LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities14 moreThis phase I trial is studying the side effects and best dose of GTI-2040 in treating patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells or by stopping them from dividing.
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated...
Acute Myeloid LeukemiaAcute Myeloid Leukemia With Myelodysplasia-Related Changes5 moreThis phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
LeukemiaAcute Myeloid Leukemia1 moreThe goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML. Objectives: To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
Myelodysplastic Syndrome (MDS)Acute Myeloid Leukemia (AML)1 moreThis study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells, combined with a substance called "MontanideTM". They are administered with granulocyte- macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune system respond to the vaccines. People 18 years of age or older with MDS, AML or CML may be eligible for this study. Participants receive six injections of the vaccines, one dose every other week for a total of 10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate injection of GM-CSF is given in the same area as the vaccine injections. Subjects are observed for 2 hours after the first vaccination and at least 30 minutes after each subsequent vaccination for allergic reactions. In addition to the vaccination, subjects undergo the following: History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy before starting the vaccinations. Safety monitoring during vaccine administration (every other week for 10 weeks) with blood tests and check of vital signs. Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray at week 12 and bone marrow biopsy visit 16.