
A Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic Anemia
Aplastic AnemiaNeutropenia2 moreBackground: Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in low blood cell counts, which require frequent transfusions. Standard initial treatment for SAA involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA). Patients with SAA who do not respond to initial treatment with ATG (refractory) have a high risk of dying without additional treatment. In these cases, for those who do not have a matched bone marrow transplant donor there is no well-defined standard therapy. In our experience with patients who do not respond to horse ATG + CsA, only about one-third of patients who are re-treated with rabbit ATG + CsA improve. Experience with cyclophosphamide in the treatment of refractory severe aplastic anemia suggests that this drug is able to improve blood counts in about 50% of cases. However, the cyclophosphamide regimen has been associated with a significant infection risk (mostly caused by fungus) in studies conducted over 10 years ago due to the lowering of the white blood cell levels. Better antibiotic drugs against fungus have been developed and are widely used to treat patients who have low white blood cell counts and are at risk of developing infections. In SAA patients in particular, these newer antibiotics have had a large impact in preventing and treating fungus infections. Researchers are revisiting the use of cyclophosphamide at lower doses to minimize its side effects given in combination with another immune suppressant, fludarabine. Objectives: - To determine the safety and effectiveness of the combination of fludarabine plus cyclophosphamide in treating severe aplastic anemia that has not responded to initial treatments.

A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia...
AnemiaChronic Renal InsufficiencyThe purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)
AnemiaAplasticThe purpose of the current study is to continue to optimize conditioning regimens in high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible unrelated donors. Specifically, the study will determine whether the addition of fludarabine to the conditioning regimen previously described by Deeg et al. will permit a reduction in the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths is reduced.

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Heart FailureAnemia3 moreThe purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
AnemiaThis study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early...
Kidney FailureChronic1 moreThe purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.

A Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) or Placebo on Anemia and Quality...
AnemiaHodgkin Disease3 moreThe purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.

Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
Sickle Cell AnemiaThe primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.

An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy...
AnemiaNeoplasmsThe purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRIT®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
AnemiaThe study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.