HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors
NCT ID: NCT01509300
Last Updated: 2012-01-13
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
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2012-01-31
2014-03-31
Brief Summary
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PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.
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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
anti-thymocyte globulin
On days -10 to -9
filgrastim
Beginning on day 4 and continuing until blood counts recover
Total body irradiation
2Gy D-6 to D-4
Fludarabine
30mg/M2 once daily IV on days -8 to -4
cyclophosphamide
60 mg/kg IV on day-3 and -2
Tacrolimus
begin on 0
Mycophenolate mofetil
begin on 0
Rituximab
375mg/m2 on day +21
Interventions
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anti-thymocyte globulin
On days -10 to -9
filgrastim
Beginning on day 4 and continuing until blood counts recover
Total body irradiation
2Gy D-6 to D-4
Fludarabine
30mg/M2 once daily IV on days -8 to -4
cyclophosphamide
60 mg/kg IV on day-3 and -2
Tacrolimus
begin on 0
Mycophenolate mofetil
begin on 0
Rituximab
375mg/m2 on day +21
Eligibility Criteria
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Inclusion Criteria
* Acute lymphoblastic leukemia (first remission, high risk; beyond first remission; refractory)
* Acute myeloblastic leukemia (first remission, high risk; beyond first remission; refractory)
* Myelodysplastic syndrome
* Solid tumors (Refractory/relapse)
2. No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available
3. HLA-haploidentical related donor available
Exclusion Criteria
2. HIV positive
3. 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
Principal investigator
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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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.
Lang P, Handgretinger R. Haploidentical SCT in children: an update and future perspectives. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S54-9. doi: 10.1038/bmt.2008.285.
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.
Other Identifiers
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AMCPHO-SCT0902
Identifier Type: -
Identifier Source: org_study_id
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