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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00726518 |
RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or by killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Monoclonal antibody therapy and chemotherapy are then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy.
PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab followed by stem cell transplant in treating patients with severe systemic lupus erythematosus.
Condition | Intervention | Phase |
---|---|---|
Precancerous/Nonmalignant Condition |
Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: methylprednisolone Drug: rituximab Procedure: autologous hematopoietic stem cell transplantation Procedure: immunologic technique Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus |
Estimated Enrollment: | 16 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Blood, bone marrow, and secondary lymphoid organs (e.g., lymph nodes and thymus either directly or indirectly) are collected periodically for biomarker studies. Patients also complete a quality of life questionnaire at baseline and periodically during follow up.
After completion of study treatment, patients are followed monthly for 6 months, at 9, 12, 18, and 24 months, and then yearly for up to 5 years.
Ages Eligible for Study: | 15 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have severe and active lupus, refractory to immunosuppressive therapy, defined as 1 of the following:
Nephritis: Biopsy-proven diffuse proliferative glomerulonephritis (WHO class IV) with or without superimposed membranous changes
Active disease, meeting 1 of the following criteria:
Treatment-resistant disease, meeting 1 of the following criteria:
CNS lupus: Lupus CNS manifestations indicative of encephalitis, myelitis, or vasculitis (clinical signs and symptoms must be supported by objective findings of CNS inflammation)
Active disease, meeting 1 of the following criteria:
Treatment-resistant disease, meeting 1 of the following criteria:
Pulmonary lupus
Active disease, meeting 1 of the following criteria:
Treatment-resistant disease, meeting 1 of the following criteria:
Hematologic disease
Active disease, meeting 1 of the following criteria:
Treatment-resistant disease, meeting 1 of the following criteria:
Must meet at least 4 of the following criteria for systemic lupus erythematosus (SLE), as defined by the American College of Rheumatology:
Serositis, meeting 1 of the following criteria:
Pleuritis
Pericarditis
Renal disorder, meeting 1 of the following criteria:
Cellular casts, meeting any of the following types:
Neurologic disorder, meeting 1 of the following criteria:
Hematologic disorder, meeting 1 of the following criteria:
Immunologic disorder, meeting 1 of the following criteria:
Positive finding of antiphospholipid antibodies based on 1 of the following:
No late flare
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
All immunosuppressive and disease-modifying treatments must be discontinued before study therapy
Study ID Numbers: | CDR0000600160, NCI-04-C-0095 |
Study First Received: | July 31, 2008 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00726518 |
Health Authority: | United States: Food and Drug Administration |
systemic lupus erythematosus |
Autoimmune Diseases Precancerous Conditions Rituximab Methylprednisolone Methylprednisolone acetate Prednisolone acetate Cyclophosphamide |
Fludarabine monophosphate Lupus Erythematosus, Systemic Prednisolone Connective Tissue Diseases Fludarabine Methylprednisolone Hemisuccinate |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Neuroprotective Agents Hormones Therapeutic Uses Alkylating Agents Immune System Diseases |
Antineoplastic Agents, Hormonal Gastrointestinal Agents Immunosuppressive Agents Protective Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |