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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most expert healthcare available for their 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 condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > 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  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
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
For Condition: Omenn syndrome,Lymphopenia,Job's Syndrome,Immunologic Deficiency Syndromes,X-linked hyper IgM syndrome,Bare Lymphocyte Syndrome,Severe Combined Immunodeficiency,Purine-Pyrimidine Metabolism, Inborn Errors,Wiskott-Aldrich Syndrome,DiGeorge Syndrome
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center ,
Synopsis: OBJECTIVES: I. Determine the safety of cyclosporine and mycophenolate mofetil as a non-ablative conditioning and post-transplantation immunosuppression regimen in patients with primary T-cell immunodeficiency disorders who undergo HLA-matched related or unrelated bone marrow transplantation to induce mixed hematopoietic chimerism (establishment of 1-95% donor CD3+ cells). II. Determine the kinetics of immune reconstitution of lymphoid cell subsets, T-cell function, and B-cell function after allogeneic bone marrow transplantation in this patient population.
Details: PROTOCOL OUTLINE: Patients are stratified according to type of primary T-cell immunodeficiency disorder (severe combined immunodeficiency syndrome (SCID) vs non-SCID) and donor status (related vs unrelated). All patients receive cyclosporine orally or IV on days -1 through 50 and oral mycophenolate mofetil on days 0 through 27 in the absence of unacceptable toxicity. Unrelated donor recipients and non-SCID patients also undergo total body irradiation on day 0. All patients then undergo allogeneic bone marrow transplantation on day 0. Cyclosporine taper regimen begins on day 50 and continues through day 180 unless evidence of graft-versus-host disease.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven primary T-cell immunodeficiency disorder - Diminished immune responses based on primary defect in T-cell immunity (deficiency in T-cell number or function) including the following diagnostic categories: Severe combined immunodeficiency syndromes (SCID): SCID with presence of B lymphocytes X-linked SCID. Autosomal recessive SCID. SCID with absence of T and B lymphocytes. Purine metabolite deficiency. Adenosine deaminase (ADA) deficiency. Purine nucleoside phosphorylase (PNP) deficiency. Other T-cell immunodeficiencies: Bare lymphocyte syndrome (BLS). Omenn's syndrome. Hyper IgM syndrome. Wiskott-Aldrich syndrome. DiGeorge syndrome. Functional T cell defects. Defects in T cell receptor-CD3 complex. Interleukin-2 deficiency. Zap70 defect. Other T-cell functional defects defined by assays or clinical syndrome No viral-associated T-cell immunodeficiency disorder (e.g., HIV). Ineligible for conventional therapy HLA-matched bone marrow donor available HLA genotypically identical OR HLA phenotypically identical unrelated Matched serologically at HLA-A and B, and molecularly at HLA-C, DRB1, and DQB1 (mismatch at HLA-C allowed if matched molecularly at HLA-A and B). --Prior/Concurrent Therapy-- - No concurrent growth factors with mycophenolate mofetil --Patient Characteristics-- - Age: 55 and under - Life expectancy: At least 30 days - Other: No other disease or organ dysfunction that would limit survival to less than 30 days
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
AnnWoolfrey, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Ann Woolfrey 206-667-4453
Additional Information:
Study ID Numbers: 199/13003; FHCRC-1227.00
Study Start Date: November 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008450
Other Wiskott-Aldrich Syndrome Studies:
1. Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
2. 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
3. Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes
Related Studies:
Other Wiskott-Aldrich Syndrome Clinical Trials
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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
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