
Effectiveness of Iron-Fortified Milk on Iron Status and Anemia in Young Children in Mexico
AnemiaIron Deficiency1 moreIron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious interventions for reducing the prevalences of iron deficiency and anemia, under controlled conditions, are available. However, little information is published about the effectiveness of large-scale programs. Objective. Assess the effectiveness on iron deficiency and anemia in young children of a large-scale program that provides iron fortified milk at a subsidized price to low income households. Design, Setting, and Sampling. A randomized effectiveness study in 12 milk distribution clusters randomly selected from 542 clusters in 4 States in Mexico. Selected clusters were randomly assigned to receive iron-fortified milk FM, N=7) or non-fortified milk (NFM, N=5). Over 95% program beneficiaries with children 12-30 mo of age in the 12 clusters (490 in FM and 275 in NFM) were enrolled in the FM and NFM interventions and participated in a baseline survey. 635 children (405 in FM and 230 in NFM) and 584 children (371 in FM and 213 in NFM) completed the 6 and 12-mo follow-up surveys, respectively. Intervention: A daily portion of FM contained 5.28 mg of iron, 48 mg of sodium ascorbate and other added micronutrients. The FM and NFM were distributed to beneficiaries at a subsidized price in Milk Distribution Centers in the 12 clusters. Main outcome measures: Mild-to-moderate anemia (Hb: 90-109 g/L), mild anemia (Hb: 100-109 g/L), moderate anemia (Hb: 90-99 g/L),iron deficiency: Serum Ferritin (SF) <12 ug/L and soluble transferring receptors (sTfR) >6 mg/L.Serum Zinc deficiency (< 65ug/dL), and stunting (<2SD Height/Age. Intervention effects at 6 and 12 moths were assessed using General Linear Mixed Models with three repeated measures.

Darbepoetin Alfa With or Without Intravenous (IV) Iron
AnemiaNon-Myeloid MalignanciesTo deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

Flexible Administration of Sprinkles® in Infants and Young Children in Rural Bangladesh.
AnemiaMillions of people worldwide are affected by iron deficiency anemia (IDA). IDA is a widespread serious public health problem, especially for infants in developing countries mainly because of inadequate intake of iron due to the poor bioavailability of dietary iron in predominately cereal based diets. One of the ways to combat iron deficiency anemia is by supplementation to targeted populations. Although iron drops have been used, they have been largely unsuccessful in reducing the prevalence of anemia because of compliance, distribution and supply issues. Sprinkles® are a new approach to iron delivery that is as efficacious as iron drops and more acceptable. For Sprinkles® to be implemented into nation-wide programs as a sustainable alternative to current iron supplementation approaches, an optimal model of use and distribution for Sprinkles® needs to be established. By comparing daily versus flexible use of Sprinkles® (60 sachets over 60, 90 and 120 days) among infants and young children aged 6-24 months, the primary objectives are to study the effect of the three administration models of Sprinkles® on changes in: hemoglobin concentration; and compliance or adherence to the intervention. ii. The secondary objective of this study is to determine the acceptability of each of the three intervention models. We hypothesize that adherence will be greater and hemoglobin concentration response will be higher in those given 'flexible' instructions to use all of the Sprinkles® supplied over a specific period of time compared to those given strict instructions for daily use.

Purine Analog-Based Conditioning in Patients With Severe Aplastic Anemia
Aplastic AnemiaPrimary Objectives: To determine the feasibility and toxicity of employing purine-analog based conditioning for allogeneic donor stem cell transplantation in patients with severe aplastic anemia (AA). To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
AnemiaRenal DiseasesThe purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring...
Renal AnemiaThe purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.

Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia...
AnemiaHemolytic1 moreThe conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the gradual reduction in dose of the drug. As a result, many patients will finally be splenectomized or be treated with long-term glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent studies have shown however, that some patients will respond to treatment with the chimeric anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the studies, Rituximab has been used in refractory disease or at least as second line treatment. In this study, patients with AIHA are randomized to receive either high-dose prednisolone with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of the patients in the two treatment arms. The primary treatment goal is a reduction in the number of patients who obtain long-term complete or partial remission. The secondary treatment goal is a reduction in patients who will be splenectomised or receive other immunosuppressive drugs. Finally a comparison of side effects of the treatments will take place.

Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT...
AMLALL11 moreThe primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.

Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking...
Aplastic AnemiaLeukemia1 moreThis is a genetic disease (transmitted through the parents' genes) called Fanconi Anemia. Because of that genetic disease, the bone marrow has changed and now has failed, or has given rise to a preleukemia called myelodysplastic syndrome (MDS) or leukemia (acute myelogenous leukemia or AML). Without treatment these complications of Fanconia anemia (FA) are fatal. The only treatment that can cure these complications is an allogeneic transplant of stem cells, meaning, giving the patient bone marrow cells from a healthy donor that can produce normal blood cells that will replace the bone marrow that is sick. What has been given for the treatment of FA in the past is to use a combination of low doses of radiation to the whole body (total body irradiation) and low doses of the chemotherapy drugs (cyclophosphamide and fludarabine) before the transplant. However, the use of radiation can, later on, increase the chances of getting a second cancer of the skin, head or the neck. These chances of a second cancer are higher than normal in patients with FA. The purpose of this study is to find out if the doctors can do the same thing with the same chemotherapy drugs used in the past. However physicians will use another chemotherapy drug called busulfan instead of the radiation. The goal of this study is to get rid of the short term and long term risks of the radiation. The first new part of this treatment will be to replace drugs for radiation with chemotherapy drugs.

Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
Myelodysplastic SyndromeAplastic AnemiaThe goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy will also be studied.