Expired Study
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Memphis, Tennessee 38105


Purpose:

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.


Study summary:

Natural killer (NK) 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. 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.


Criteria:

Inclusion Criteria: - Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease. - Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery - Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT. Exclusion Criteria: - Participants who are pregnant - Participants with inadequate renal, liver, or pulmonary functions


NCT ID:

NCT00187096


Primary Contact:

Principal Investigator
Jeffrey E. Rubnitz, M.D.
St. Jude Children's Research Hospital


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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