Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
- Determine the maximum tolerated dose of recombinant BL22 immunotoxin in patients with
CD22-positive refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia,
or indolent non-Hodgkin's lymphoma.
- Determine the safety and efficacy of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine 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 nonrandomized, dose-escalation study. Patients are stratified according
to disease type (chronic lymphocytic leukemia vs non-Hodgkin's lymphoma).
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5.
Treatment repeats ≥ every 27 days for up to 6 courses in the absence of neutralizing
antibodies to BL22 or PE38, disease progression, or unacceptable toxicity. Patients
achieving a complete response (CR) receive 2 additional courses beyond CR. Patients who
relapse from a CR lasting ≥ 6 months may receive additional courses.
Cohorts of 3-6 patients per stratum 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 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 24 patients (12 per stratum) will be accrued for this study
within 1-2 years.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert Kreitman, MD
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|