Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic Anemia
NCT ID: NCT01759732
Last Updated: 2013-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2012-09-30
2015-12-31
Brief Summary
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Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for children with acquired severe aplastic anemia
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HAPLO
Fludarabine
40mg/M2 once daily IV on days -7 to -4
Cyclophosphamide
60 mg/kg IV on day-3 and -2
anti-thymocyte globulin
filgrastim
Total body irradiation
200 cGy per day on D-5 \& -4
CD3-depleted hematopoietic cell transplantation
Immunogenetic depletion on CliniMACS
Interventions
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Fludarabine
40mg/M2 once daily IV on days -7 to -4
Cyclophosphamide
60 mg/kg IV on day-3 and -2
anti-thymocyte globulin
filgrastim
Total body irradiation
200 cGy per day on D-5 \& -4
CD3-depleted hematopoietic cell transplantation
Immunogenetic depletion on CliniMACS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Granulocyte count \< 500/mm3,
* Corrected reticulocyte count \< 1%,
* Platelet count \< 20,000/mm3
* No HLA-identical family member or closely matched (8 of 8 HLA-locus match) unrelated marrow donor available
* HLA-haploidentical related donor available
Exclusion Criteria
* Clonal cytogenetic abnormalities or myelodysplastic syndromes
* Active fungal infections
* HIV positive
* Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure
* Pregnant or nursing
21 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Ho Joon Im
Professor
Principal Investigators
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Ho Joon Im, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Burroughs LM, Woolfrey AE, Storer BE, Deeg HJ, Flowers ME, Martin PJ, Carpenter PA, Doney K, Appelbaum FR, Sanders JE, Storb R. Success of allogeneic marrow transplantation for children with severe aplastic anaemia. Br J Haematol. 2012 Jul;158(1):120-8. doi: 10.1111/j.1365-2141.2012.09130.x. Epub 2012 Apr 26.
Tolar J, Deeg HJ, Arai S, Horwitz M, Antin JH, McCarty JM, Adams RH, Ewell M, Leifer ES, Gersten ID, Carter SL, Horowitz MM, Nakamura R, Pulsipher MA, Difronzo NL, Confer DL, Eapen M, Anderlini P. Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels. Biol Blood Marrow Transplant. 2012 Jul;18(7):1007-11. doi: 10.1016/j.bbmt.2012.04.014. Epub 2012 Apr 27.
Xu LP, Liu KY, Liu DH, Han W, Chen H, Chen YH, Zhang XH, Wang Y, Wang FR, Wang JZ, Huang XJ. A novel protocol for haploidentical hematopoietic SCT without in vitro T-cell depletion in the treatment of severe acquired aplastic anemia. Bone Marrow Transplant. 2012 Dec;47(12):1507-12. doi: 10.1038/bmt.2012.79. Epub 2012 May 28.
Koh KN, Im HJ, Kim BE, Choi ES, Jang S, Kwon SW, Park CJ, Seo JJ. Haploidentical haematopoietic stem cell transplantation using CD3 or CD3/CD19 depletion and conditioning with fludarabine, cyclophosphamide and antithymocyte globulin for acquired severe aplastic anaemia. Br J Haematol. 2012 Apr;157(1):139-42. doi: 10.1111/j.1365-2141.2011.08924.x. Epub 2011 Nov 5. No abstract available.
Im HJ, Koh KN, Suh JK, Lee SW, Choi ES, Jang S, Kwon SW, Park CJ, Seo JJ. Refinement of treatment strategies in ex vivo T-cell-depleted haploidentical SCT for pediatric patients. Bone Marrow Transplant. 2015 Feb;50(2):225-31. doi: 10.1038/bmt.2014.232. Epub 2014 Oct 13.
Related Links
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Other Identifiers
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AMCPHO-SCT1202
Identifier Type: -
Identifier Source: org_study_id
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