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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: | NCT00187096 |
The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.
Condition | Intervention |
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Acute Myeloid Leukemia |
Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2 Procedure: Natural Killer Cell Infusion Device: CliniMACS System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia |
Estimated Enrollment: | 27 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stratum 1: Experimental
Stratum 1 (AML in complete remission) Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0 |
Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
See Detailed Description section for additional details of treatment interventions.
Procedure: Natural Killer Cell Infusion
See Detailed Description section for additional details of treatment interventions.
Device: CliniMACS System
See Detailed Description section for additional details of treatment interventions.
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Stratum 2: Experimental
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease) Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0. |
Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
See Detailed Description section for additional details of treatment interventions.
Procedure: Natural Killer Cell Infusion
See Detailed Description section for additional details of treatment interventions.
Device: CliniMACS System
See Detailed Description section for additional details of treatment interventions.
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Natural killer cells extracted from a [parental] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.
Secondary objectives of this study are:
Details of Treatment Plan:
Stratum 1 (AML in complete remission)
Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
For patients who have received prior SCT, the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor.
Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three times per week for two weeks (6 doses) starting on the evening of day -1.
NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will be infused on day 0.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey E Rubnitz, 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: Jeffrey E Rubnitz, MD PhD 866-278-5833 info@stjude.org | |
Principal Investigator: Jeffrey E Rubnitz, MD PhD |
Principal Investigator: | Jeffrey E. Rubnitz, M.D. | St. Jude Children's Resarch Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Jeffrey E. Rubnitz, MD / Principal Investigator ) |
Study ID Numbers: | NKAML |
Study First Received: | September 12, 2005 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00187096 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Myeloid Acute |
Clofarabine Immunologic Factors Leukemia, Myeloid Cyclophosphamide Fludarabine monophosphate Leukemia, Myeloid, Acute Etoposide phosphate Immunosuppressive Agents Leukemia Acute Myelocytic Leukemia |
Analgesics, Non-Narcotic Interleukin-2 Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents Etoposide |
Clofarabine Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid Cyclophosphamide Leukemia, Myeloid, Acute Immunosuppressive Agents Pharmacologic Actions Leukemia |
Neoplasms Sensory System Agents Analgesics, Non-Narcotic Interleukin-2 Therapeutic Uses Myeloablative Agonists Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |