Expired Study
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Minneapolis, Minnesota 55455


Purpose:

A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.


Criteria:

Inclusion Criteria (Recipient): - Meets ONE of the following disease criteria: 1. Primary AML induction failure: no CR after 2 or more induction attempts 2. Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy 3. AML relapsed > 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed. 4. Relapsed AML for patients > 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met: - Relapse within 6 months of last chemotherapy - BM blast count < 30% within 10 days of starting protocol therapy - Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I serologic typing at the A&B locus - Karnofsky Performance Status ≥ 60% - Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration - Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications). - Agrees to use contraception prior to study entry and for the duration of study participation. Exclusion Criteria (Recipient): - Bi-phenotypic acute leukemia. - Transplant < 60 days prior to study enrollment. - Active autoimmune disease. - History of severe asthma - Uncontrolled intercurrent illness - New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy - Pleural effusion large enough to be detectable on chest x-ray. - Pregnant women - History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection - Known hypersensitivity to any of the study agents used - Received investigational drugs within the 14 days of study registration. - Known active CNS involvement. Criteria For Initial Donor Selection: - Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling). - 14-75 years of age. - At least 40 kilogram body weight. - In general good health as determined by the evaluating medical provider. - HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus. - Not pregnant. - Able and willing to undergo apheresis.


NCT ID:

NCT02395822


Primary Contact:

Principal Investigator
Jeffrey Miller, MD
Masonic Cancer Center, University of Minnesota


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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