MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients

Inclusion criteria

(Recipient):

• Meets ONE of the following disease criteria:

• Primary AML induction failure: no CR after 2 or more induction attempts
• Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
• AML relapsed > 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
• 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.