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Protocol No. 2012IS042 Principal Investigator Bachanova, Veronika
Phase Phase I
Age Group Adult Scope National
Secondary Protocol No. AO-101
Title HM2012-26 : A Phase I Study of De-immunized DI-Leu16-IL2 Immunocytokine in Patients with B-cell Non-Hodgkin Lymphoma
Objective 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
Treatment 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).
Description 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.
Key Eligibility 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 Non-Hodgkin's Lymphoma
Drugs Involved DI-Leu 16 IL-2
Status Open
Participating Institutions Masonic Cancer Center : Veronika Bachanova
Detailed Eligibility 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/Burkitt’s 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.
Treatment Type Treatment
Contact Veronika Bachanova Phone:612-625-5469
Email:bach0173@umn.edu
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