||HM2013-12 : IL-15 Agonists to Treat Relapse of Heme Malignancy after Allogeneic Transplantation
||To determine the optimal (best) dose of ALT-803 when given as a once a week infusion for 4 weeks in a row.
||ALT-803 ( study drug) as a short IV infusion once a week for 4 weeks in a row.
||This study involves treatment with ALT-803, a new agent which is a super agonist of Interleukin-15 (IL-15). IL-15 is a cytokine (a type of protein), which is naturally occurring in humans. Super agonist is a general term given to any drug or agent that is capable of producing a greater maximal response than what is based on. The study is trying to find the best dose of ALT-803 to treat certain types of cancer.
||Pts who are ≥ 18 yrs of age and have relapsed ≥ 60 days post allogeneic stem cell transplantation for one of the following hematologic malignancies:
Acute myelogenous leukemia (AML),Acute lymphoblastic leukemia (ALL),
Myelodysplastic syndromes (MDS), Lymphoma,Myeloma ,Chronic Lymphocytic Leukemia (CLL), and Chronic myelogenous leukemia (CML) who have failed or refused TKI and DLI
|Applicable Disease Sites
Leukemia, not otherwise specified
Myeloid and Monocytic Leukemia
||Masonic Cancer Center
||Pts must have adequate renal, hepatic, cardiac and lung function, no indicators of acute or chronic GVDH requiring systemic treatment. Pts can not have ongoing active acute or chronic GVHD requiring systemic immunosuppressive therapies. Pts need to be off prednisone and other systemic immunosuppressants for at least 30 days prior to 1st dose of study drug
Prior DLI permitted but must be at least 30 days between DLI and 1st dose of ALT-803
Post-transplant lymphoproliferative diseases are not eligible