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Protocol No. 2012LS023 Principal Investigator Miller, Jeffrey
Phase Phase I/II
Age Group Adult Scope National
Title HM2013-12 : IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic Stem Cell Transplantation
Objective To determine the optimal (best) dose of ALT-803 when given as a once a week infusion for 4 weeks in a row.
Treatment ALT-803 ( study drug) as a short IV infusion once a week for 4 weeks in a row.
Description 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.
Key Eligibility 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 Hodgkin's Lymphoma
Leukemia, not otherwise specified
Leukemia, other
Lymphoid Leukemia
Multiple Myeloma
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Hematopoietic
Drugs Involved ALT-803
Status Open
Participating Institutions Masonic Cancer Center
WashU Barnes Jewish Hospital
WashU Siteman Cancer Center Infusion Center
WashU Siteman Cancer Center West County
Washington University
Detailed Eligibility 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
Treatment Type Treatment
Contact Judith Witte Phone:612-626-0169
Email:mirab001@umn.edu
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