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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553098 |
RATIONALE: Giving chemotherapy, such as fludarabine, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal cells.
PURPOSE: This phase II trial is studying giving fludarabine and total-body irradiation with or without alemtuzumab followed by a donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders.
Condition | Intervention | Phase |
---|---|---|
Precancerous/Nonmalignant Condition |
Drug: alemtuzumab Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Hematopoietic Cell Transplantation for Treatment of Patients With Primary Immunodeficiencies and Other Nonmalignant Inherited Disorders Using Low-Dose TBI and Fludarabine With or Without Campath® |
Estimated Enrollment: | 35 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of HSCT, patients are followed at day 84, at 6, 12, 18 and 24 months post-transplantation, and then once a year for 3 years.
Ages Eligible for Study: | up to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Suitable related or unrelated donor available, meeting the following criteria:
Related donor who is HLA genotypically identical at least at one haplotype and may be genotypically or phenotypically identical for serological typing for HLA-A, -B, -C, and at the allele level for -DRB1 and -DQB1
Unrelated donor who is matched at HLA-A, -B, -C, -DRB1 and -DQB1 by DNA typing at the highest resolution routinely available at the time of donor selection
PATIENT CHARACTERISTICS:
No hepatic conditions for patients with clinical or laboratory evidence of liver disease in terms of liver function and the degree of portal hypertension, including the following:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt Children's Hospital | Recruiting |
Nashville, Tennessee, United States, 37232-9700 | |
Contact: Haydar Frangoul, MD 800-811-8480 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Lauri Burroughs, MD 206-667-2396 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Lauri Burroughs, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Lauri Burroughs ) |
Study ID Numbers: | CDR0000573405, FHCRC-2007.00 |
Study First Received: | November 2, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00553098 |
Health Authority: | Unspecified |
precancerous/nonmalignant condition |
Cyclosporine Precancerous Conditions Clotrimazole Miconazole Alemtuzumab Tioconazole |
Mycophenolate mofetil Fludarabine Fludarabine monophosphate Cyclosporins Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |