Finding studies
Finding studies
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Lead
City of Hope Medical Center
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of DI-Leu16-IL2 (DI-Leu16-IL2 immunocytokine) following peripheral blood B cell depletion with rituximab in patients with B-cell NHL. II. To investigate the optimal biological 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. III. To describe the toxicities associated with the proposed DI-Leu16-IL2 regimen. SECONDARY OBJECTIVES: I. To evaluate the immunogenicity as measured by the induction of DI-Leu16-IL2-specific antibodies. II. To evaluate the pharmacokinetics of DI-Leu16-IL2. III. To document any clinical responses associated with the proposed therapy and survival endpoints of the enrolled patients. OUTLINE: This is a dose-escalation study of DI-Leu16-IL2 immunocytokine. Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays. Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 5 years.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
