Lymphoma Clinical Trial
Official title:
Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing
substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients
who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody
4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic
lymphocytic leukemia.
- Assess the clinical toxicity of this antibody in these patients.
OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.
Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2
hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6
patients experience dose-limiting toxicity.
Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1
year.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
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