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Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus Clinical research trials and Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus. Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus  Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: No longer recruiting
Sponsor(s): Northwestern Memorial Hospital ,
Synopsis: OBJECTIVES: I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.
Details: PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro. Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0. Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /59 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of systemic lupus erythematosus with 1 of the following malignant features: - Nephritis (WHO class III or IV) - Failed NIH short-course cyclophosphamide therapy - Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure) - Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following: Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL Platelet count less than 40,000/mm3 (without transfusions) Granulocyte count less than 1,000/mm3 Catastrophic anti-phospholipid syndrome --Patient Characteristics-- Cardiovascular: - LVEF at least 35% - No lupus-induced myocarditis - No history of unstable angina Pulmonary: - FEV1/FVC at least 50% predicted - DLCO at least 50% predicted Other: - HIV negative - No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer - No uncontrolled diabetes mellitus - No medical illness that would preclude study - No psychiatric illness or mental deficiency that would preclude study - No known hypersensitivity to E. coli-derived proteins - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
AnnTraynor, Study Chair, Northwestern Memorial Hospital
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
United States
Additional Information:
Study ID Numbers: 199/14976; NU-95LU1
Study Start Date: April 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017641
Other Systemic Lupus Erythematosus Studies:
1. Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
2. Drug Therapy in Lupus Nephropathy
3. Safety of Estrogens in Lupus: Birth Control Pills
4. Prevention of Arthritis-Related Work Disability
5. Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
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Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
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