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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00228852 |
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Date of registration:
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27/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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IMM 0212: Busulfan With Fludarabine and Antithymocyte Globulin as Preparative Therapy for Hematopoietic Stem Cell Transplant for the Treatment of Severe Congenital T-Cell Immunodeficiency
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Scientific title:
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Phase I/II Trial of De-Escalation of Busulfan With Fludarabine and Antithymocyte Globulin as Preparative Therapy for Hematopoietic Stem Cell Transplant for the Treatment of Severe Congenital T-Cell Immunodeficiency |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00228852 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Naynesh R Kamani, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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George Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with the following primary severe T-cell immune deficiency diseases and
donor types will be eligible for this pilot trial:
- Immunophenotype: SCIDs with decreasing T, any B, increasing natural killer (NK)
with partial matched family member, unrelated donor marrow or cord blood, with
or without T depletion; OR
- Combined immunodeficiency disease (CID), including Wiskott-Aldrich and severe
DiGeorge's with any donor type.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Combined Immunodeficiency
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T-Cell Immune Deficiency Diseases
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Intervention(s)
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Drug: Busulfan, Fludarabine and ATG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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