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| Sponsor: | Richard Burt |
|---|---|
| Information provided by (Responsible Party): | Richard Burt, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00278538 |
Purpose
This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Procedure: Hematopoietic stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet one of following five:
Exclusion Criteria:
Contacts and Locations| Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
| United States, Illinois | |
| Northwestern University, Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Richard Burt, MD | |
| Sub-Investigator: Kathleen Quigley, R.N | |
| Sub-Investigator: Kimberly Young, RN | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Richard Burt, MD | |
| Principal Investigator: | Richard Burt, MD | Northwestern University |
More Information
| Responsible Party: | Richard Burt, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00278538 History of Changes |
| Other Study ID Numbers: | DI SLE.Auto2003 |
| Study First Received: | January 15, 2006 |
| Last Updated: | August 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Cyclophosphamide Rituximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |