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RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAPLO | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | On days -10 to -9 |
| |
| filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells. | 2 years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment and graft failure rates | Number of patients who failed to stable engraftment by 28 days | 28 days engraftment and graft failure |
| Incidence of acute GVHD | Number of patients with acute GVHD. |
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Inclusion Criteria
Disease characteristics
No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available
HLA-haploidentical related donor available
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho Joon Im, MD & PhD | Contact | 82-2-3010-3371 | hojim@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ho Joon Im, MD & PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22055111 | Background | 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. | |
| 18978746 |
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| Biological |
Beginning on day 4 and continuing until blood counts recover |
|
| Total body irradiation | Radiation | 2Gy D-6 to D-4 |
|
| Fludarabine | Drug | 30mg/M2 once daily IV on days -8 to -4 |
|
| cyclophosphamide | Drug | 60 mg/kg IV on day-3 and -2 |
|
| Tacrolimus | Drug | begin on 0 |
|
| Mycophenolate mofetil | Drug | begin on 0 |
|
| Rituximab | Drug | 375mg/m2 on day +21 |
|
| 100 days post-transplant |
| Treatment related mortality | Number of death after transplantation | 100 days post-transplant |
| Relapse rate and overall survival | 2 year after transplantation |
| Background |
| 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. |
| 25310303 | Derived | 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. |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000069585 | Filgrastim |
| D014916 | Whole-Body Irradiation |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
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