Lymphoma Clinical Trial
Official title:
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal
cells.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating
patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
OBJECTIVES:
- Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in
patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic
leukemia.
- Determine the pharmacokinetics, including the terminal elimination serum half-life area
under the curve and volume of distribution, of recombinant BL22 immunotoxin in these
patients.
- Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
- Determine the effect of recombinant BL22 immunotoxin on various components of the
circulating cellular immune system in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5.
Patients may be retreated at least every 20 days for up to 25 courses in the absence of
disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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