Safety Study Looking at the Use of a Natural Killer Cell Line Against Hematological Malignancies

This is an interventional treatment trial for Leukemia focused on measuring natural killer cells, leukemia, lymphoma, myeloma, Hodgkin's disease, cell therapy Read More

Inclusion Criteria:

• Hematological malignancy (with prior histological confirmation) that has relapsed after an autologous stem cell transplant and for which there is no known curative or standard therapy. Specific hematological malignancies include acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma.
• Assessable disease as measured by clinical, radiological or bone marrow examinations
• ECOG performance status 0, 1 or 2
• Age ≥ 18 years
• Life expectancy greater than 12 weeks
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and University Human Experimentation Committee requirements.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: Absolute granulocytes ≥ 0.5 x 109/L, Platelets ≥ 50 x 109/L, Serum creatinine < 1.5 x upper limit of normal, Bilirubin < 1.5 x upper limit of normal, AST/ALT ≤ 3 x upper limit of normal, Calcium < 1.25 x upper limit of normal. These tests must be conducted within 7 days prior to registration.
• Must be able to come to Princess Margaret Hospital, Toronto, Canada for treatment and follow-up.

Exclusion Criteria:

• Pregnant or nursing women may not participate.
• Men or women of reproductive potential may not participate unless they agree to practice an effective method of birth control. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to registration.
• Concurrent treatment, or treatment within 28 days of registration with other experimental drugs or anticancer therapy. Exceptions to this are: Patients who are receiving or who have received radiation therapy less than four weeks prior to study entry will not be excluded providing the volume of bone marrow treated is less than 10% and that the patient has measurable disease outside the radiation field. Hydroxyurea may be administered to patients with high white cell counts but must be discontinued at least 48 hours prior to the NK-92 cell infusions
• Patients with CNS involvement
• Known HIV, HBV or HCV infection
• Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular events within 3 months of registration, or psychiatric or emotional disorders.
• Patients with hypersensitivity or previous severe reactions to Allopurinol, Acetominophen or Benadryl and all available alternative medications.