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Anemia, Aplastic clinical trials

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NCT ID: NCT00017654 Active, not recruiting - Clinical trials for Graft Versus Host Disease

Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

Start date: April 2001
Phase: N/A
Study type: Interventional

OBJECTIVES: I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation.

NCT ID: NCT00011830 Completed - Aplastic Anemia Clinical Trials

Stem Cell Mobilization Potential in Patients With Aplastic Anemia in Remission

Start date: February 2001
Phase: Phase 1
Study type: Interventional

This study will examine 1) whether it is possible to collect enough stem cells (cells produced by the bone marrow that mature into white and red blood cells and platelets) from patients with aplastic anemia to use for future treatment, and 2) whether patients who have been treated successfully and relapse will benefit from autologous stem cell transfusion (transfusion of their own stem cells). Patients 12 years of age or older with aplastic anemia who have been successfully treated with immunosuppressive drugs and are now in remission may be eligible for this study. Participants will undergo a complete history and physical examination, bone marrow biopsy (removal of a small sample of bone marrow from the hip bone) and blood tests, plus procedures to collect stem cells, as follows: - G-CSF (Filgrastim) administration - G-CSF will be given by injection under the skin daily for up to 10 days. This drug causes stem cells to move from the marrow into the blood where they can be collected more easily. - Apheresis - Stem cells will be collected through apheresis, usually starting the 5th to 6th day of Filgrastim injections. For this procedure, whole blood is collected through a needle in an arm vein. The blood circulates through a cell separator machine where the white cells and stem cells are removed. The red cells, platelets and plasma are returned to the body through a second needle in the other arm. The procedure takes about 5 hours. Up to five procedures, done on consecutive days, may be required to collect enough cells for transplantation. If enough cells are collected, they will be purified (treated to remove the white blood cells) using an experimental device. Removing the lymphocytes may reduce the chance of relapse of aplastic anemia following the stem cell transplant. The stem cells will be frozen for later use, if needed. - Follow-up - Participants are followed at NIH at 6-month intervals.

NCT ID: NCT00011453 Completed - Leukemia Clinical Trials

Protection Against Benzene Toxicity

Start date: July 1998
Phase: N/A
Study type: Observational

We are investigating the role of an enzyme (NQO1) in protection against the bone marrow toxicity of the occupational and environmental toxicant benzene. All of the proposed studies involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated protection. Cells are obtained from healthy volunteers and protocols have undergone IRB review and approval.

NCT ID: NCT00006300 Completed - Aplastic Anemia Clinical Trials

Oral Manifestations of Aplastic Anemia

Start date: April 2000
Phase: N/A
Study type: Observational

The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral complications in patients with aplastic anemia; 2) to evaluate if oral problems in these patients can predict their response to treatment; and 3) to review complications of dental treatment in these patients in order to establish treatment guidelines. This study will be performed through a review of medical charts of 79 patients with aplastic anemia and 67 patients with schizophrenia who were treated at the National Institutes of Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a control population. Demographic, clinical and radiographic information will be collected for all patients. Additional data collected only for aplastic anemia patients will include medical therapy, disease duration, blood cell counts, oral problems that developed during treatment and treatment response.

NCT ID: NCT00005935 Completed - Aplastic Anemia Clinical Trials

Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia

Start date: June 2000
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of a new drug combination for treating patients with severe aplastic anemia. Patients with aplastic anemia produce too few blood cells, causing fatigue, easy bruising and bleeding, and susceptibility to infections. In many cases, the very low blood counts result from an autoimmune process-that is, the patient's own immune system suppresses production of blood cells by the bone marrow. Although immune-suppressing drugs, such as cyclosporine, can restore normal cell counts, many patients have disease relapses. These patients require long-term therapy with cyclosporine, which can cause harmful side effects. This study will examine whether a lower dose of cyclosporine given together with mycophenolate mofetil (MMF) can maintain blood counts as effectively as full-dose cyclosporine treatment, and whether MMF alone can reduce the chances of future relapses. Patients 4 years of age and older with severe aplastic anemia who have relapsed after immune suppressing therapy may be eligible for this study. Participants will be randomly assigned to receive either standard cyclosporine therapy or experimental therapy with cyclosporine and MMF. Patients receiving standard cyclosporine therapy will receive a full dose of the drug for at least 3 months. Those taking both cyclosporine and MMF will take MMF plus half-dose cyclosporine for 3 months and continue MMF for an additional 6 months. Both drugs are taken twice a day by mouth. All patients will have about 120 milliliters (4 ounces) of blood drawn at the beginning of the study to evaluate immune system activity and bone marrow function, and to look for genetic material of certain viruses. Bone marrow aspirations and biopsies will be done at the beginning of the study, and at 6 and 12 months. For these tests, the area of the hip is anesthetized and a special needle is used to draw bone marrow from the hipbone. The patient's local doctor will be asked to do blood tests for chemistries, liver function and cyclosporine levels weekly for the first month and then every other week. Patients will return to NIH for evaluations 3, 6 and 12 months after treatment and then once a year. About 100 ml (7 tablespoons) of blood will be drawn at each visit.

NCT ID: NCT00005682 Completed - Blood Disease Clinical Trials

Aplastic Anemia Epidemiology: Incidence and Case-control

Start date: September 1988
Phase: N/A
Study type: Observational

To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand

NCT ID: NCT00005307 Completed - Blood Disease Clinical Trials

Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data

Start date: April 1989
Phase: N/A
Study type: Observational

To quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia.

NCT ID: NCT00005302 Completed - Blood Disease Clinical Trials

Drug Etiology of Aplastic Anemia and Related Dyscrasias

Start date: April 1985
Phase: N/A
Study type: Observational

To determine the role of drugs in the etiology of aplastic anemia, agranulocytosis, and thrombocytopenic purpura. Drugs used in chemotherapy and immunotherapy were excluded.

NCT ID: NCT00004474 Completed - Aplastic Anemia Clinical Trials

Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia

Start date: September 1998
Phase: Phase 3
Study type: Interventional

OBJECTIVES: I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.

NCT ID: NCT00004464 Completed - Aplastic Anemia Clinical Trials

Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

Start date: February 1996
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia. II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients. III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.