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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00569179 |
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
Condition | Intervention | Phase |
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Leukemia, Myeloid, Acute Leukemia, Lymphoid Myelodysplastic Syndromes Leukemia, Myelogenous, Chronic |
Device: CliniMACS CD34 Reagent System |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES |
Estimated Enrollment: | 24 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Wood, RN | 317-274-1781 | llwood@iupui.edu |
Contact: Sherif Farag, MD, PhD | 317-274-0843 | ssfarag@iupui.edu |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Lisa Wood, RN 317-274-1781 llwood@iupui.edu | |
Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu |
Principal Investigator: | Sherif Farag, MD, PhD | Indiana University School of Medicine |
Responsible Party: | Indiana University Cancer Center ( Sherif Farag, MD/ Principal Investigator ) |
Study ID Numbers: | 0612-26/ IUCRO-0179 |
Study First Received: | December 5, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00569179 |
Health Authority: | United States: Food and Drug Administration |
Myeloid Malignancies Bone Marrow Transplant AML |
ALL MDS CML |
Myelodysplastic syndromes Leukemia, Lymphoid Immunoproliferative Disorders Precancerous Conditions Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders |
Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Lymphatic Diseases Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome |