Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
- Determine the response rate in patients with cladribine-resistant hairy cell leukemia
treated with BL22 immunotoxin.
- Determine the response duration in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate BL22 blood levels and toxicity of this drug with the development of
neutralizing antibodies in these patients.
OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed
Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission
are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3,
and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving CR without minimal residual
disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses
Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
After even cycle numbers (2,4,6,8,10)
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|