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| ID | Type | Description | Link |
|---|---|---|---|
| IRB # 2007-13271 |
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The hypothesis of this study is that children with severe primary immunodeficiencies will benefit from early stem cell transplantation utilizing a reduced intensity conditioning regimen. This regimen is associated with a low risk of complications and will lead to correction of the underlying immunological defects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine, Busulfan, and Anti-Thymocyte Globulin | Drug | Patients on this study will receive 5 days of Fludarabine, 1 day of Busulfan Test Dose, 2 Days of Busulfan Regimen Dose, and 4 days of Anti-Thymocyte Globulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of an optimized reduced intensity conditioning regimen using Fludarabine, Busulfan, and Anti-Thymocyte Globulin in preparing severe immunodeficiency patients for allogeneic hematopoietic progenitor cell transplantation | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To prospectively follow the natural course of severe immunodeficiency diseases after transplantation | 5 years | |
| To measure the outcomes after stem cell transplantation using the reduced intensity transplant regimen. | 5 years |
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Inclusion Criteria:
Must show one of the following diseases:
Informed Consent
Adequate Renal Function
Adequate Liver Function
Adequate Cardiac Function
Adequate Pulmonary Function
Adequate Performance Statue
Adequate Venous Access
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morris Kletzel, MD | Contact | 773-880-4562 | mkletzel@childrensmemorial.org | |
| Colleen E Schaefer, BS | Contact | 773-880-3459 | cschaefer@childrensmemorial.org |
| Name | Affiliation | Role |
|---|---|---|
| Morris Kletzel, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hospital | Recruiting | Chicago | Illinois | 60614 | United States |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |