|Secondary Protocol No.
||HM2012-26 : A Phase I Study of De-immunized DI-Leu16-IL2 Immunocytokine in Patients with B-cell Non-Hodgkin Lymphoma
||1. To determine the maximum tolerated dose (MTD) of DI-Leu16-IL2 administered SC following peripheral blood B cell depletion with rituximab in patients with B-cell NHL.
2. To investigate the optimal biologic dose (OBD) of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL, which may differ from the MTD.
3. To describe the toxicities
||Following peripheral blood B cell depletion with rituximab (if needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection for three consecutive days every three weeks (21 day cycle).
||This is an open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20 positive NHL that have failed standard rituximab-containing therapy.
||Patients greater than or equal to 18 yrs of age with CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy and have received prior rituximab-containing therapy and have measurable disease.
|Applicable Disease Sites
||DI-Leu 16 IL-2
||Masonic Cancer Center
||Patients must have CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy. Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with peripheral blood leukemia/lymphoma cells and high-grade lymphomas (i.e. Lymphoblastic Lymphoma/Burkitts Lymphoma) are excluded.
2. Patients must have received prior rituximab-containing therapy and have measurable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable. However, patients with bone marrow involvement alone will not be included in the study.
4. Patients who have received a prior autologous stem cell transplant are eligible if the transplant occurred > 6 months ago.
5. Patients who have received a prior allogeneic stem cell transplant are eligible if:
a. The transplant occurred > 6 months ago
b. There is no evidence of active graft vs host disease
c. Systemic immunosuppressive agents (including corticosteriods) have not been received for at least 8 weeks.
Patients with bulky LNs (> 10 cm) or marked splenomegaly (i.e. extending into pelvis or crossing the midline) are not eligible. A signed informed consent and HIPPA authorization are required.