View clinical trials related to Myelodysplastic Syndromes.
Filter by:Primary: To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT) performed for AML or high-risk MDS.
Primary objectives: - To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen - To evaluate the pharmacokinetic (PK) profile of SAR103168 Secondary objectives: - To characterize the global safety profile of SAR103168 - To evaluate preliminary anti-leukemia activity - To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD - To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites - To determine the potential impact of SAR103168 on the QTc interval in patients enrolled at the MTD
This study will assess the safety, tolerability, and pharmacokinetics in AML and high risk MDS patients with either wild type or mutated FLT3 using PKC412 with intra-patient dose escalation.
The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.
The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.
The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation
RATIONALE: Studying immune response to flu vaccine in patients who have undergone a stem cell transplant may help doctors plan the best treatment. PURPOSE: This clinical trial is studying flu vaccine to see how well it works in preventing infection in patients who have undergone a stem cell transplant and in healthy volunteers.
Background: - Myelodysplastic syndromes (MDS) are bone marrow disorders characterized by anemia, neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet counts). Patients with MDS are at risk for symptomatic anemia, infection, and bleeding, as well as a risk of progression to acute leukemia. Standard treatments for MDS have significant relapse rates. MDS patients with thrombocytopenia who fail standard therapies require regular, expensive, and inconvenient platelet transfusions, and are at risk for further serious bleeding complications. - Eltrombopag is a drug designed to mimic the protein thrombopoietin, which causes the body to make more platelets. Eltrombopag has been able to increase platelet counts in healthy volunteers and in patients with chronic ITP (a disease where patients destroy their own platelets very rapidly and thus develop thrombocytopenia), but researchers do not know if the drug can increase platelet counts in patients with MDS. Objectives: - To find out whether eltrombopag can improve platelet counts in patients with MDS. - To determine whether eltrombopag is safe for patients with MDS. Eligibility: - Patients 18 years of age and older who have consistently low blood platelet counts related to MDS that has not responded to conventional treatment. - Platelet count ≤ 30,000/μL or platelet-transfusion-dependence (requiring at least 4 platelet transfusions in the 8 weeks prior to study entry); OR hemoglobin less than 9.0 gr/dL or red cell transfusion-dependence (requiring at least 4 units of PRBCs in the eight weeks prior to study entry) OR ANC≤500 Design: - Treatment with eltrombopag tablets once per day for 16-20 weeks. - Participants will be monitored closely throughout the initial treatment, with weekly blood tests and separate evaluations at the National Institutes of Health (NIH) treatment center every 4 weeks. Bone marrow biopsies may be conducted to check for abnormalities in bone marrow. - If patients show signs of improved platelet counts after 90 days, treatment will continue with additional doses of eltrombopag. - Patients who discontinue taking eltrombopag will be evaluated at the NIH treatment center 4 weeks after ending treatment, and again 6 months after ending treatment to check for potential side effects.
The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.