IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT

Inclusion Criteria

• •Relapse after previous allogeneic stem cell transplant for one of the following hematologic malignancies (acute myelogenous leukemia, acute lymphoblastic leukemia,myelodysplastic syndromes, lymphoma, myeloma, Chronic lymphocytic Leukemia, chronic myelogenous leukemia):
• •* For non-CML, relapse will be defined based on disease specific morphologic criteria from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics. For disease specific definition of relapse, see appendix III. Relapse can be determined morphologically. Equivocal results for relapse should result in a repeated test after an appropriate time interval (suggested 1 month) to determine eligibility.
• •For Chronic Phase CML patients only:
• •must have failed (no response in 3 months or incomplete response at 6 months) or refused treatment with a tyrosine-kinase inhibitor (TKI)
• •must have failed (defined as incomplete response or relapse) or refused DLI
• •Relapse must have occurred ≥ 60 days after transplant
• •Prior DLI is allowed, however not within the 30 days before the 1st dose of ALT-803
• •Minimum donor chimerism of 10%
• •≥ 18 years of age
• •Karnofsky performance status ≥ 70% (appendix II)
• •Adequate organ function within 14 days (30 days for cardiac and pulmonary) of enrollment defined as:
• •* Creatinine: ≤ 2.0 mg/dL
• •* Hepatic: SGOT/SGPT \< 5 x upper limit of institutional normal (ULN)
• •* Pulmonary: PFTs \> 50% of predicted
• •* Cardiac: LVEF by ECHO or MUGA \> 40%
• •Ability to be off prednisone and other immunosuppressive drugs for at least 30 day before first dose of study drug
• •Patient agrees to stay within a reasonable distance (i.e. 30 miles) of the study site for the duration of the study treatment and for a minimum of 48 hours after the last dose and has a dedicated care giver as is standard practice for BMT outpatient care
• •Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
• •Voluntary written consent