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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00145626 |
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor).
Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Acute Lymphocytic Leukemia Myelodysplasia Chronic Myeloid Leukemia Histiocytosis |
Drug: Chemotherapy and antibodies Device: Miltenyi Biotec CliniMACS Procedure: Allogeneic stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies |
Estimated Enrollment: | 33 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Drug: Chemotherapy and antibodies
Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and OKT3 followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.
Device: Miltenyi Biotec CliniMACS
Stem cell selection device
Procedure: Allogeneic stem cell transplantation
Allogeneic natural killer (NK)cell infusion
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Secondary objectives for this study include the following:
Ages Eligible for Study: | up to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have one of the following diagnosis:
Contact: Wing H. Leung, M.D., PhD | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Wing H. Leung, M.D., PhD 866-278-5833 info@stjude.org | |
Principal Investigator: Wing H. Leung, M.D., PhD |
Principal Investigator: | Wing H. Leung, M.D., PhD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Wing H. Leung, M.D., PhD / Principal Investigator ) |
Study ID Numbers: | INF-T2 |
Study First Received: | September 1, 2005 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00145626 |
Health Authority: | United States: Food and Drug Administration |
Stem cell transplantation Stem cell transplant Haploidentical transplant |
Neural Tube Defects Melphalan Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Chronic myelogenous leukemia Nervous System Malformations Cyclophosphamide Leukemia, Myeloid, Acute Muromonab-CD3 Leukemia Preleukemia Histiocytosis Congenital Abnormalities Lymphoma |
Acute myelocytic leukemia Immunoglobulins Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Myeloproliferative Disorders Fludarabine monophosphate Leukemia, Myeloid Thiotepa Lymphatic Diseases Antibodies |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Reticuloendotheliosis Immune System Diseases Nervous System Diseases |