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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303667 |
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving donor natural killer cells before the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying how well a donor natural killer cell infusion works in treating patients who are undergoing donor stem cell transplant for acute myeloid leukemia, chronic myeloid leukemia, or myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Reduced Intensity Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Supplemented With Donor Natural Killer (NK) Cell Infusions |
Estimated Enrollment: | 45 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive fludarabine IV over 1 hour daily on days -17 to -13, cyclophosphamide IV over 2 hours on day
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following high-risk (aggressive) myeloid malignancies:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | Sarah Cooley, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Sarah Cooley ) |
Study ID Numbers: | CDR0000450770, UMN-2004LS042, UMN-MT2003-23, UMN-IRB-0405M60481 |
Study First Received: | March 15, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00303667 History of Changes |
Health Authority: | Unspecified |
adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia de novo myelodysplastic syndromes |
previously treated myelodysplastic syndromes secondary myelodysplastic syndromes secondary acute myeloid leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia childhood myelodysplastic syndromes |
Antimetabolites Blast Crisis Immunologic Factors Precancerous Conditions Leukemia, Myeloid, Chronic-Phase Cyclophosphamide Leukemia, Myeloid, Acute Leukemia Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Neoplasm Metastasis Congenital Abnormalities Alkylating Agents Hematologic Diseases |
Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Fludarabine monophosphate Immunosuppressive Agents Recurrence Acute Myeloid Leukemia, Childhood Antilymphocyte Serum Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Antineoplastic Agents, Alkylating Chronic Myelogenous Leukemia Fludarabine Antirheumatic Agents Bone Marrow Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses Alkylating Agents |
Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neoplasms Myeloablative Agonists Leukemia, Myelogenous, Chronic, BCR-ABL Positive Antineoplastic Agents, Alkylating Fludarabine |