Leukemia Clinical Trial
Official title:
Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal
cells. This may be an effective treatment for hairy cell leukemia.
PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients
who have refractory or recurrent hairy cell leukemia.
OBJECTIVES:
- Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in
patients with refractory or recurrent CD22+ hairy cell leukemia.
- Define the pharmacokinetics of this drug, including the terminal elimination serum
half-life area under the curve and volume of distribution, in these patients.
- Evaluate the immunogenicity of this drug in these patients.
- Determine the effect of this drug 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.
Treatment repeats at least every 42 days for up to 4 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 at which no more
than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.
;
Primary Purpose: Treatment
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