|
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies Clinical research trials and Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies clinical trial. Human subjects often obtain the finest healthcare possible for their Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies  Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
For Condition: Immunologic Deficiency Syndromes,Chediak-Higashi Syndrome,Leukocyte Adhesion Deficiency Syndrome,Common Variable Immunodeficiency,Graft Versus Host Disease,Hemophagocytic Lymphohistiocytosis,Virus-Associated Hemophagocytic Syndrome,X-linked agammaglobulinemia,Wiskott-Aldrich Syndrome,Chronic Granulomatous Disease,X-Linked Lymphoproliferative Syndrome,Severe Combined Immunodeficiency,Familial Erythrophagocytic Lymphohistiocytosis,X-linked hyper IgM syndrome
Status: No longer recruiting
Sponsor(s): Fairview University Medical Center ,
Synopsis: OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation for patients with primary immunodeficiencies. II. Determine relevant outcomes of this treatment in these patients including quality of survival, extent of morbidity and mortality from complications of the treatment (e.g., graft versus host disease, regimen related toxicities, B- cell lymphoproliferative disease), and completeness of functional immunoreconstitution.
Details: PROTOCOL OUTLINE: Patients with severe combined immunodeficiency (SCID) using a matched sibling donor receive allogeneic bone marrow or umbilical cord blood transplantation on day 0. Patients receive graft versus host disease (GVHD) prophylaxis with methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV on days -3 to 50. Patients with SCID using donors other than histocompatible siblings, Wiskott Aldrich syndrome using a histocompatible sibling donor, Wiskott Aldrich syndrome and under 5 years of age using donors other than histocompatible siblings, X-linked CD40 ligand deficiency using a histocompatible sibling donor, X-linked CD40 ligand deficiency and under 5 years of age using donors other than histocompatible siblings, other primary immunodeficiencies without manifestations of hemophagocytosis using a histocompatible sibling donor, or other primary immunodeficiencies without manifestations of hemophagocytosis and under 5 years of age using donors other than histocompatible siblings receive busulfan IV over 2 hours every 6 hours on days -9 to -6, cyclophosphamide IV on days -5 to -2, and antithymocyte globulin (ATG) twice daily on days -4 to -1. Allogeneic bone marrow or umbilical cord blood transplantation takes place on day 0. Patients receive graft versus host disease (GVHD) prophylaxis with methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV on days -3 to 50. Patients with hemophagocytic lymphohistiocytosis, Chediak Higashi syndrome, X-linked lymphoproliferative syndrome, severe progressive Langerhans cell histiocytosis, or other primary immunodeficiencies with complications of hemophagocytosis receive busulfan IV over 2 hours every 6 hours on days -9 to -6, cyclophosphamide IV over 2 hours on days -5 to -2, etoposide IV over 22 hours on days -5 to -3, and ATG IV twice daily on days -2, -1, 1, and 2. Allogeneic bone marrow or umbilical cord blood transplantation takes place on day 0. Patients receive graft versus host disease (GVHD) prophylaxis with methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV on days -3 to 50. Patients with Wiskott Aldrich syndrome or other primary immunodeficiencies without manifestations of hemophagocytosis, who are over 5 years of age and using donors other than histocompatible siblings, receive busulfan IV over 2 hours every 6 hours on days -6 and -5, cyclophosphamide IV over 2 hours on days -4 and -3, total body irradiation on day -2, and ATG IV over 2 hours twice daily on days -2, -1, 2, and 3. Allogeneic bone marrow or umbilical cord blood transplantation takes place on days 0 and 1. Patients receive GVHD prophylaxis with methylprednisolone IV every 12 hours on days 2-21, oral prednisone every 12 hours on days 22-100 and then tapered off over days 101 to 128, and cyclosporine IV over 2 hours every 8-12 hours on days -3 to 100. All patients are followed as determined by their primary physician.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /35 Years
Genders: Both
Protocol Entry Criteria: - Severe combined immunodeficiency All ages with histocompatible sibling donors or with other donors OR Wiskott Aldrich syndrome All ages with histocompatible sibling donors or with other donors OR X-linked CD40 ligand deficiency All ages with histocompatible sibling donors OR Under 5 years of age with donors other than histocompatible siblings OR Other primary immunodeficiencies without manifestations of hemophagocytosis All ages with histocompatible sibling donors or with other donors OR Hemophagocytic lymphohistiocytosis (HLH) Familial erythrophagocytic lymphohistiocytosis (FEL), familial HLH (FHLH), recurrent virus-associated hemophagocytic syndrome (VAHS) All ages with related or unrelated donors OR Chediak Higashi syndrome All ages with related or unrelated donors OR X-linked lymphoproliferative syndrome All ages with related or unrelated donors OR Other primary immunodeficiencies with complication of hemophagocytosis All ages with related or unrelated donors OR Severe progressive Langerhans cell histiocytosis All ages with related or unrelated donors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
K.Baker, Study Chair, Fairview University Medical Center
Fairview University Medical Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: 199/15104; UMN-MT-1995-26,UMN-MT-9526
Study Start Date: March 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006054
Other Familial Erythrophagocytic Lymphohistiocytosis Studies:
1. Pilot Study of Allogeneic Bone Marrow Transplantation Plus Cyclosporine and Mycophenolate Mofetil to Induce Mixed Hematopoietic Chimerism in Patients With Primary T-Cell Immunodeficiency Disorders
2. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
3. Use of G-CSF to Obtain Blood Cell Precursors
4. Gene Transfer Therapy for Severe Combined Immunodeficieny Disease (SCID) due to Adenosine Deaminase (ADA) Deficiency: A Natural History Study
5. Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID
Related Studies:
Other Familial Erythrophagocytic Lymphohistiocytosis Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
|
|
|
|
|
|
|
|
