Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas
- Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or
refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the immunogenicity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients
with acute lymphoblastic leukemia.
- Determine the therapeutic efficacy of this drug in inducing remissions in these
- Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and
soluble cytokine receptor levels in patients treated with this drug.
OUTLINE: This is a non-randomized, dose-escalation study.
Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5,
7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients who achieve a complete response (CR) or
unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6
Cohorts of 3-6 patients receive escalating doses of 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. Once the MTD is determined, the
cohort is expanded and a total of 12 patients are treated at that dose.
Patients are followed weekly for at least 1 month and then every 1-3 months thereafter.
PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
assessment of efficacy, safety, pharmacokinetics, immunogenicity.
end of study
Alan S. Wayne, 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|