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| Descriptive Information Fields | |||||
| Brief Title † | Anti-CD45 Monoclonal Antibody, Alemtuzumab, and Fludarabine Followed By Donor Stem Cell Transplant in Treating Children With Severe Combined Immunodeficiency Disease or Other Primary Immunodeficiency Disorder | ||||
| Official Title † | CD45 (YTH-24 and YTH 54) and Alemtuzumab (CamPath-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Donor Stem Cell Transplantation of Patients With Severe Combined Immunodeficiency Disease and Other Primary Immunodeficiency Disorders | ||||
| Brief Summary | RATIONALE: Giving monoclonal antibodies, such anti-CD45 monoclonal antibody and alemtuzumab, and chemotherapy drugs, such as fludarabine, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase I trial is studying the side effects and how well giving anti-CD45 monoclonal antibody together with alemtuzumab and fludarabine followed by donor stem cell transplant works in treating patients with severe combined immunodeficiency disease or other primary immunodeficiency disorder. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive alemtuzumab IV on days -8 to -6, fludarabine IV on days -8 to -4, and anti-CD45 monoclonal antibody IV over 6 hours on days -5 to -2. Patients undergo allogeneic stem cell transplantation on day 0. After completion of study treatment, patients are followed periodically. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | T-cell function [ Designated as safety issue: No ] B-cell function [ Designated as safety issue: No ] Donor hematopoiesis [ Designated as safety issue: No ] Toxicity [ Designated as safety issue: Yes ] Incidence of grade III-IV acute graft-versus-host disease [ Designated as safety issue: Yes ] 1-year survival rate [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Precancerous/Nonmalignant Condition | ||||
| Intervention † | Drug: alemtuzumab Drug: anti-CD45 monoclonal antibody Drug: fludarabine phosphate Procedure: allogeneic hematopoietic stem cell transplantation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 21 | ||||
| Start Date † | December 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | up to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00609258 | ||||
| Organization ID | CDR0000582364 | ||||
| Secondary IDs †† | BCM-H-21123, BCM-MASCI | ||||
| Study Sponsor † | Baylor College of Medicine | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | January 30, 2008 | ||||
| Last Updated Date | October 8, 2008 | ||||