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Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) The Assisi Foundation |
Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00640796 |
Modern frontline therapy for patients with hematologic malignancies is based on intensive administration of multiple drugs. In patients with relapsed disease, response to the same drugs is generally poor, and dosages cannot be further increased without unacceptable toxicities. For most patients, particularly those who relapse while still receiving frontline therapy, the only therapeutic option is hematopoietic stem cell transplantation (SCT). For those who relapse after transplant, or who are not eligible for transplant because of persistent disease, there is no proven curative therapy.
There is mounting evidence that NK cells have powerful anti-leukemia activity. In patients undergoing allogeneic SCT, several studies have demonstrated NK-mediated anti-leukemic activity. NK cell infusions in patients with primary refractory or multiple-relapsed leukemia have been shown to be well tolerated and void of graft-versus-host disease (GVHD) effects. Myeloid leukemias are particularly sensitive to NK cells cytotoxicity, while B-lineage acute lymphoblastic leukemia (ALL) cells are often NK-resistant.
We have developed a novel method to expand NK cells and enhance their cytotoxicity. Expanded and activated donor NK cells have shown powerful anti-leukemic activity against acute myeloid leukemia (AML) cells and T-lineage ALL cells in vitro and in animal models of leukemia.
The present study represents the translation of these laboratory findings into clinical application.. We propose to determine the safety of infusing expanded NK cells in pediatric patients who have chemotherapy refractory or relapse hematologic malignancies including AML, T-lineage ALL, T-cell lymphoblastic lymphoma (T-LL), chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML), and myelodysplastic syndrome (MDS). The NK cells used for this study will be obtained from the patient's family member who will be a partial match to the patient's immune type (HLA type).
Condition | Intervention | Phase |
Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Acute, T-Cell Juvenile Myelomonocytic Leukemia Lymphoblastic T-Cell Lymphoblastic Lymphoma Myelodysplastic Syndrome |
Procedure: Haploidentical donor derived natural killer cell infusion Drug: Chemotherapy (Cyclophosphamide, Fludarabine, Interleukin-2, Mesna) Device: CliniMACS |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
ChemIDplus related topics: | Mesna Cyclophosphamide Fludarabine Fludarabine monophosphate Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies |
Estimated Enrollment: | 18 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Infusion with expanded Natural Killer cells
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Procedure: Haploidentical donor derived natural killer cell infusion
Therapeutic cell infusion
Drug: Chemotherapy (Cyclophosphamide, Fludarabine, Interleukin-2, Mesna)
Cyclophosphamide, Fludarabine, Interleukin-2, Mesna
Device: CliniMACS
Cell selection system based on magnetic-activated cell sorting
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Secondary objectives include the evaluation of the in vivo lifespan and phenotype of the expanded NK cells and explore the efficacy of these donor NK cells in study participants.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Dario Campana, MD, PhD | 1-866-278-5833 | info@stjude.org |
Contact: Wing Leung, MD, PhD | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |||||
St. Jude Children's Research Hospital | Recruiting | ||||
Memphis, Tennessee, United States, 38105 | |||||
Contact: Dario Campana, MD, PhD 866-278-5833 info@stjude.org |
St. Jude Children's Research Hospital |
National Cancer Institute (NCI) |
The Assisi Foundation |
Principal Investigator: | Dario Campana, MD, PhD | St. Jude Children's Research Hospital |
St. Jude Children's Research Hospital 
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Responsible Party: | St. Jude Children's Research Hospital ( Dario Campana, MD, PhD / Princiapal Investigator ) |
Study ID Numbers: | NKEXP |
First Received: | March 14, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00640796 |
Health Authority: | United States: Food and Drug Administration |
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